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FDA 510(k)

HICHEM ALP/AMP REAGENT KIT

K-Number: K963383 · 1996-09-23

ApplicantHichem Diagnostics
Decision Date1996-09-23
Product CodeCKF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HICHEM ALP/AMP REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Hichem Diagnostics. It received FDA 510(k) clearance on 1996-09-23 under 510(k) number K963383. The device is classified under product code CKF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HICHEM ALP/AMP REAGENT KIT?

HICHEM ALP/AMP REAGENT KIT is a medical device that received FDA 510(k) clearance on 1996-09-23. The listed applicant is Hichem Diagnostics. The 510(k) number is K963383.

When did HICHEM ALP/AMP REAGENT KIT receive FDA 510(k) clearance?

HICHEM ALP/AMP REAGENT KIT received FDA 510(k) clearance on 1996-09-23, under 510(k) number K963383.

Who is the listed applicant for HICHEM ALP/AMP REAGENT KIT?

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

What is the FDA product code for HICHEM ALP/AMP REAGENT KIT?

The FDA product code for HICHEM ALP/AMP REAGENT KIT is CKF.

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Other records listing Hichem 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.

K981794HICHEM CALCIUM REAGENT KITK953860HICHEM ISE DILUENT KIT 70008K953863HICHEM ISE STANDARDS KIT 70011K953862HICHEM ISEKCI SOLUTION KIT 70010K953861HICHEM ISE INTDERNAL REFERENCE KIT 70009K951751HICHEM AST REAGENT KIT

View all 41 devices →

Related Devices (Code: CKF)

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.

K072142S40 CLINICAL ANALYZER, S TEST ALP, S TEST AMYLASE, S TEST ASTAlfa Wassermann Diagnostic Technologies, 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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