FDA 510(k), K881577, MODIFIED SELECTIVE STREPTOCOCCUS AGAR

FDA 510(k), K881577, MODIFIED SELECTIVE STREPTOCOCCUS AGAR

Regular price $89.00 USD
Regular price Sale price $89.00 USD
Sale Sold out
510(K) Number: K881577
Device Name: MODIFIED SELECTIVE STREPTOCOCCUS AGAR
Manufacturer:
Device Classification Name: Culture Media, Selective And Differential
Regulation Number: 866.2360
Classification Product Code: JSI
Date Received: 04/11/1988
Decision Date: 04/18/1988
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or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.”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