FDA 510(k), K933121, MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR

FDA 510(k), K933121, MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR

Regular price $89.00 USD
Regular price Sale price $89.00 USD
Sale Sold out
510(K) Number: K933121
Device Name: MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR
Manufacturer:
Device Classification Name: Culture Media, For Isolation Of Pathogenic Neisseria
Regulation Number: 866.2410
Classification Product Code: JTY
Date Received: 06/25/1993
Decision Date: 02/03/1994
Regulation Medical Specialty: Microbiology

PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.

View full details