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FDA 510(k)

HICHEM ENZYME VERIFIER KIT

K-Number: K943684 · 1994-10-04

ApplicantHi Chem, Inc.
Decision Date1994-10-04
Product CodeJJT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HICHEM ENZYME VERIFIER KIT is the device name listed in this FDA 510(k) record. The listed applicant is Hi Chem, Inc.. It received FDA 510(k) clearance on 1994-10-04 under 510(k) number K943684. The device is classified under product code JJT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HICHEM ENZYME VERIFIER KIT?

HICHEM ENZYME VERIFIER KIT is a medical device that received FDA 510(k) clearance on 1994-10-04. The listed applicant is Hi Chem, Inc.. The 510(k) number is K943684.

When did HICHEM ENZYME VERIFIER KIT receive FDA 510(k) clearance?

HICHEM ENZYME VERIFIER KIT received FDA 510(k) clearance on 1994-10-04, under 510(k) number K943684.

Who is the listed applicant for HICHEM ENZYME VERIFIER KIT?

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

What is the FDA product code for HICHEM ENZYME VERIFIER KIT?

The FDA product code for HICHEM ENZYME VERIFIER KIT is JJT.

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Other records listing Hi Chem, 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.

K960084HICHEM GLUCOSE/HK REAGENT KITK951818HICHEM ALT REAGENT KITK941764HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808K902673HI CHEM TOTAL PROTEIN/ALBUMIN SERUM RANGE LIN STNDK863617ION 2/4 FLOW CELL CLEANER (PRODUCT #88656)K862027LDP REAGENT CARTRIDGE (NO. 88216)

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Related Devices (Code: JJT)

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.

K090940SPOTCHECK BLOOD SPOT CONTROL, ASSAYEDAstoria-Pacific, Inc.K062751MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKERQuantimetrix Corp.K030768CLINIQA LIQUID QC CARDIAC MARKER CONTROL LEVELS 1, 2 & 3, TRI-LEVELCliniqa CorporationK030102ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3Bayer Healthcare, LLCK021498LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1, 2, 3, AND TRILEVELBio-RadK012656LIQUICHEK CARDIAC MARKERS CONTROL LT LEVEL 1,2,3, MODELS 646,647,648Bio-Rad

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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