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FDA 510(k)

QUICK CEPT

K-Number: K801668 · 1980-08-13

ApplicantLaboratory Diagnostics Co., Inc.
Decision Date1980-08-13
Product CodeJHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

QUICK CEPT is the device name listed in this FDA 510(k) record. The listed applicant is Laboratory Diagnostics Co., Inc.. It received FDA 510(k) clearance on 1980-08-13 under 510(k) number K801668. The device is classified under product code JHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QUICK CEPT?

QUICK CEPT is a medical device that received FDA 510(k) clearance on 1980-08-13. The listed applicant is Laboratory Diagnostics Co., Inc.. The 510(k) number is K801668.

When did QUICK CEPT receive FDA 510(k) clearance?

QUICK CEPT received FDA 510(k) clearance on 1980-08-13, under 510(k) number K801668.

Who is the listed applicant for QUICK CEPT?

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

What is the FDA product code for QUICK CEPT?

The FDA product code for QUICK CEPT is JHS.

Related Clinical Trials

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.

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Other records listing Laboratory Diagnostics Co., Inc. 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.

K761232QUICK CULT SLIDE TEST FECAL OCCULT BLOOD

Related Devices (Code: JHS)

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.

K160570Creatine KinaseRoche Diagnostics Operations (Rdo)K102706CKMB UDR ASSAYSENTINEL CH. SpAK082226S40 CREATINE KINASE (CK)Alfa Wassermann Diagnostic Technologies, Inc.K062128THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYSDade Behring, Inc.K990434CARESIDE CKMBCareside, Inc.K990439CARESIDE CKCareside, Inc.

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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