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FDA 510(k)

HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE

K-Number: K852867 · 1985-08-29

ApplicantHi Chem, Inc.
Decision Date1985-08-29
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE 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 1985-08-29 under 510(k) number K852867. 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 HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE?

HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE is a medical device that received FDA 510(k) clearance on 1985-08-29. The listed applicant is Hi Chem, Inc.. The 510(k) number is K852867.

When did HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE receive FDA 510(k) clearance?

HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE received FDA 510(k) clearance on 1985-08-29, under 510(k) number K852867.

Who is the listed applicant for HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE?

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 HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE?

The FDA product code for HI-CHEM DIAGNOSTICS ENZYME RINSE CONCENTRATE 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 KITK951818HICHEM ALT 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)

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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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