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FDA 510(k)

SULFATE, FIBRIQUIK PROTAMINE

K-Number: K781814 · 1978-11-08

ApplicantGeneral Diagnostics
Decision Date1978-11-08
Product CodeJBN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SULFATE, FIBRIQUIK PROTAMINE is the device name listed in this FDA 510(k) record. The listed applicant is General Diagnostics. It received FDA 510(k) clearance on 1978-11-08 under 510(k) number K781814. The device is classified under product code JBN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SULFATE, FIBRIQUIK PROTAMINE?

SULFATE, FIBRIQUIK PROTAMINE is a medical device that received FDA 510(k) clearance on 1978-11-08. The listed applicant is General Diagnostics. The 510(k) number is K781814.

When did SULFATE, FIBRIQUIK PROTAMINE receive FDA 510(k) clearance?

SULFATE, FIBRIQUIK PROTAMINE received FDA 510(k) clearance on 1978-11-08, under 510(k) number K781814.

Who is the listed applicant for SULFATE, FIBRIQUIK PROTAMINE?

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 SULFATE, FIBRIQUIK PROTAMINE?

The FDA product code for SULFATE, FIBRIQUIK PROTAMINE is JBN.

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Other records listing General Diagnostics as applicant

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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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Official Source

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

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