FDA 510(k)

STREPTACOCCUS CO-AGGLUTINATION KIT

K-Number: K822799 · 1982-12-19

Decision Date1982-12-19

Product CodeGTP

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

STREPTACOCCUS CO-AGGLUTINATION KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Scientific Products. It received FDA 510(k) clearance on 1982-12-19 under 510(k) number K822799. The device is classified under product code GTP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STREPTACOCCUS CO-AGGLUTINATION KIT?

STREPTACOCCUS CO-AGGLUTINATION KIT is a medical device that received FDA 510(k) clearance on 1982-12-19. The listed applicant is American Scientific Products. The 510(k) number is K822799.

When did STREPTACOCCUS CO-AGGLUTINATION KIT receive FDA 510(k) clearance?

STREPTACOCCUS CO-AGGLUTINATION KIT received FDA 510(k) clearance on 1982-12-19, under 510(k) number K822799.

Who is the listed applicant for STREPTACOCCUS CO-AGGLUTINATION KIT?

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

What is the FDA product code for STREPTACOCCUS CO-AGGLUTINATION KIT?

The FDA product code for STREPTACOCCUS CO-AGGLUTINATION KIT is GTP.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing American Scientific Products as applicant

K864824INFECTIOUS TISSUE KIT K844042BLOOD DILUTION VIAL K831634GLUCOSE REAGENT B6360-11 K831625UREA NITROGEN-BUN-REAGENTS B6360-12 K831626UREA NITROGEN-BUN-REAGENTS B6370-11A K831628CREATININE REAGENTS B6370-13

View all 28 devices →

Related Devices (Code: GTP)

K860041STREP D FLUORBio Spec, Inc.K833738LEAP STREP TEST KITCooper Biomedical, 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.