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FDA 510(k)

VERIFY S PROD. #34141

K-Number: K800925 · 1980-07-21

ApplicantGeneral Diagnostics
Decision Date1980-07-21
Product CodeGGW
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VERIFY S PROD. #34141 is the device name listed in this FDA 510(k) record. The listed applicant is General Diagnostics. It received FDA 510(k) clearance on 1980-07-21 under 510(k) number K800925. The device is classified under product code GGW. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERIFY S PROD. #34141?

VERIFY S PROD. #34141 is a medical device that received FDA 510(k) clearance on 1980-07-21. The listed applicant is General Diagnostics. The 510(k) number is K800925.

When did VERIFY S PROD. #34141 receive FDA 510(k) clearance?

VERIFY S PROD. #34141 received FDA 510(k) clearance on 1980-07-21, under 510(k) number K800925.

Who is the listed applicant for VERIFY S PROD. #34141?

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

What is the FDA product code for VERIFY S PROD. #34141?

The FDA product code for VERIFY S PROD. #34141 is GGW.

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Other records listing General Diagnostics 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.

K882663BARBITURATE ENZYME IMMUNOASSAY KITK872882CANNABINOID ENZYME IMMUNOASSAY KITK871305COCAINE METABOLITE ENZYME IMMUNOASSAY KITK864993QUALI. ENZYME IMMUNO. OF BARBITURATES IN URINEK863877BENZODIAZEPINE ENZYME IMMUNOASSAY KITK842307GENERAL DIAG. CEFONICID 30MCG ANTIMIC

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Related Devices (Code: GGW)

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.

K260551HemosIL Factor V Leiden (APC Resistance V)Instrumentation Laboratory (IL) Co.K090105LUPOTEK KCTR2 Diagnostics, Inc.K083729HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHENAniara Diagnostica, LLCK060284CRYOCHECK CLOT APCRPrecision Biologic, Inc.K042762PEFAKIT APC-R FACTOR V LEIDENPentapharm , Ltd.K033471PHOSPHOLIN ES AND CALCIUM CHLORIDER2 Diagnostics, 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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