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FDA 510(k)

MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT

K-Number: K902237 · 1990-07-09

ApplicantMedica Corp.
Decision Date1990-07-09
Product CodeDBL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medica Corp.. It received FDA 510(k) clearance on 1990-07-09 under 510(k) number K902237. The device is classified under product code DBL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT?

MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT is a medical device that received FDA 510(k) clearance on 1990-07-09. The listed applicant is Medica Corp.. The 510(k) number is K902237.

When did MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT receive FDA 510(k) clearance?

MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT received FDA 510(k) clearance on 1990-07-09, under 510(k) number K902237.

Who is the listed applicant for MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT?

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

What is the FDA product code for MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT?

The FDA product code for MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT is DBL.

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Other records listing Medica Corp. 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.

K123802EASYRA TBIL REAGENT, EASYRA DBII REAGENT, EASYRA CK REAGENTK120497EASYRA HBALC REGENT EASYCAL HBLC CALIBRATOR EASYQC HBALC MATERIALK111363PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIALK111005ETHANOL REAGENT, ETHANOL CALIBRATOR, ETHANOL QC MATERIALK112788EASTLYTE NA/K/CA/PHK101089EASYRA MICRO-ALBUMIN REAGENT AND CALIBRATOR

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Related Devices (Code: DBL)

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.

K180202Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno ConceptsImmuno Concepts, N.A. , Ltd.K980312NOVA LITE ENDOMYSIALInova Diagnostics, Inc.K974169WIELISA ANTI-GBM TEST SYSTEMWieslab ABK971464IMMUNOSCAN ANTI-GBM QUANTITATIVE KITEuro-Diagnostica ABK971658MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KITJay H. GellerK963525DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KITShield Diagnostics, Ltd.

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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