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FDA 510(k)

CK REAGENT CARTRIDGE (PRODUCT NO. 88213)

K-Number: K861879 · 1986-05-29

ApplicantHi Chem, Inc.
Decision Date1986-05-29
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CK REAGENT CARTRIDGE (PRODUCT NO. 88213) 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 1986-05-29 under 510(k) number K861879. The device is classified under product code CGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CK REAGENT CARTRIDGE (PRODUCT NO. 88213)?

CK REAGENT CARTRIDGE (PRODUCT NO. 88213) is a medical device that received FDA 510(k) clearance on 1986-05-29. The listed applicant is Hi Chem, Inc.. The 510(k) number is K861879.

When did CK REAGENT CARTRIDGE (PRODUCT NO. 88213) receive FDA 510(k) clearance?

CK REAGENT CARTRIDGE (PRODUCT NO. 88213) received FDA 510(k) clearance on 1986-05-29, under 510(k) number K861879.

Who is the listed applicant for CK REAGENT CARTRIDGE (PRODUCT NO. 88213)?

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 CK REAGENT CARTRIDGE (PRODUCT NO. 88213)?

The FDA product code for CK REAGENT CARTRIDGE (PRODUCT NO. 88213) is CGS.

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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: CGS)

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.

K191296Pointe Scientific Creatinine Kinase (CK) Reagent SetMedtest DXK182702SEKURE Creatine Kinase AssaySekisui Diagnostics P.E.I., Inc.K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 CalibratorSiemens Healthcare Diagnostics, Inc.K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATORRandox Laboratories, Ltd.K112416CPK REAGENTVital Diagnostics (Manufacturing) PtyltdK083465DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGESiemens Healthcare Diagnostics

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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