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FDA 510(k)

SIMPLATE

K-Number: K761250 · 1977-03-01

ApplicantGeneral Diagnostics
Decision Date1977-03-01
Product CodeJCA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SIMPLATE is the device name listed in this FDA 510(k) record. The listed applicant is General Diagnostics. It received FDA 510(k) clearance on 1977-03-01 under 510(k) number K761250. The device is classified under product code JCA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMPLATE?

SIMPLATE is a medical device that received FDA 510(k) clearance on 1977-03-01. The listed applicant is General Diagnostics. The 510(k) number is K761250.

When did SIMPLATE receive FDA 510(k) clearance?

SIMPLATE received FDA 510(k) clearance on 1977-03-01, under 510(k) number K761250.

Who is the listed applicant for SIMPLATE?

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 SIMPLATE?

The FDA product code for SIMPLATE is JCA.

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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: JCA)

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.

K911745SIMPLATE PEDIATRICOrganon Teknika Corp.K911996SURGICUTT-BLEEDING TIME DEVICE, MODIFICATIONInternational Technidyne Corp.K871318Q.I.C. BLEEDING TIME DEVICEHelena LaboratoriesK850542SURGICUTT - BLEEDING TIME DEVICEInternational Technidyne Corp.K830645BLEEDING TIME DEVICE DISPOSABLEAmerican DadeK801815AUTOLETUlster Scientific, 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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