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FDA 510(k)

HICHEM ALT REAGENT KIT

K-Number: K951818 · 1995-05-15

ApplicantHi Chem, Inc.
Decision Date1995-05-15
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HICHEM ALT REAGENT 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 1995-05-15 under 510(k) number K951818. The device is classified under product code CKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HICHEM ALT REAGENT KIT?

HICHEM ALT REAGENT KIT is a medical device that received FDA 510(k) clearance on 1995-05-15. The listed applicant is Hi Chem, Inc.. The 510(k) number is K951818.

When did HICHEM ALT REAGENT KIT receive FDA 510(k) clearance?

HICHEM ALT REAGENT KIT received FDA 510(k) clearance on 1995-05-15, under 510(k) number K951818.

Who is the listed applicant for HICHEM ALT REAGENT 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 ALT REAGENT KIT?

The FDA product code for HICHEM ALT REAGENT KIT is CKA.

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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 KITK943684HICHEM ENZYME VERIFIER 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: CKA)

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.

K120945HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ASTHitachi Chemical Diagnostics, Inc.K113382ACE ALT REAGENTAlfa WassermannK061020DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASEDade Behring, Inc.K020487CARESIDE ALTCareside, Inc.K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.K973869TRACE REAGENT LINE FOR THE COBAS MIRATrace America, 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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