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FDA 510(k)

CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI

K-Number: K812188 · 1981-08-31

ApplicantAmerican Scientific Products
Decision Date1981-08-31
Product CodeGMD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI 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 1981-08-31 under 510(k) number K812188. The device is classified under product code GMD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI?

CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI is a medical device that received FDA 510(k) clearance on 1981-08-31. The listed applicant is American Scientific Products. The 510(k) number is K812188.

When did CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI receive FDA 510(k) clearance?

CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI received FDA 510(k) clearance on 1981-08-31, under 510(k) number K812188.

Who is the listed applicant for CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI?

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 CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI?

The FDA product code for CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI is GMD.

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Other records listing American Scientific 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.

K864824INFECTIOUS TISSUE KITK844042BLOOD DILUTION VIALK831634GLUCOSE REAGENT B6360-11K831625UREA NITROGEN-BUN-REAGENTS B6360-12K831626UREA NITROGEN-BUN-REAGENTS B6370-11AK831628CREATININE REAGENTS B6370-13

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Related Devices (Code: GMD)

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.

K112422CRAG LATERAL FLOW ASSAY (LFA)Immuno-Mycologics, Inc.K102286CRAG LATERAL FLOW ASSAY (CRAG LFA)Immuno-Mycologics, Inc.K930418CRYPTO-LEX SYSTEMTrinity Laboratories, Inc.K933997PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAYAlexon Biomedical, Inc.K894845(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASEMeridian Diagnostics, Inc.K810510YA-CRYPTO ANTIBODY TUBE AGGLUTINATIONImmuno-Mycologics, 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.

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