Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TRYPTICASE SOY AGAR W/5% RABBIT BLD. CEL

K-Number: K802994 · 1980-12-22

ApplicantSacks Farms Biological Products
Decision Date1980-12-22
Product CodeJSH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

TRYPTICASE SOY AGAR W/5% RABBIT BLD. CEL is the device name listed in this FDA 510(k) record. The listed applicant is Sacks Farms Biological Products. It received FDA 510(k) clearance on 1980-12-22 under 510(k) number K802994. The device is classified under product code JSH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRYPTICASE SOY AGAR W/5% RABBIT BLD. CEL?

TRYPTICASE SOY AGAR W/5% RABBIT BLD. CEL is a medical device that received FDA 510(k) clearance on 1980-12-22. The listed applicant is Sacks Farms Biological Products. The 510(k) number is K802994.

When did TRYPTICASE SOY AGAR W/5% RABBIT BLD. CEL receive FDA 510(k) clearance?

TRYPTICASE SOY AGAR W/5% RABBIT BLD. CEL received FDA 510(k) clearance on 1980-12-22, under 510(k) number K802994.

Who is the listed applicant for TRYPTICASE SOY AGAR W/5% RABBIT BLD. CEL?

The FDA 510(k) record lists Sacks Farms Biological Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRYPTICASE SOY AGAR W/5% RABBIT BLD. CEL?

The FDA product code for TRYPTICASE SOY AGAR W/5% RABBIT BLD. CEL is JSH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sacks Farms Biological Products as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K802995TRYPTICASE SOY AGAR W/5% SHEEP BLD. CELLK801775SERO STREP KIT

Related Devices (Code: JSH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K881553RUSSELL DOUBLE SUGAR AGARAcumedia Manufacturers, Inc.K881559UREA AGAR BASEAcumedia Manufacturers, Inc.K881486DNASE TEST AGARAcumedia Manufacturers, Inc.K881540FLO AGARAcumedia Manufacturers, Inc.K881551PHENOL RED BROTH BASEAcumedia Manufacturers, Inc.K881560UREA BROTHAcumedia Manufacturers, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑