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FDA 510(k)

HICHEM CK/NAC REAGENT KIT

K-Number: K962247 · 1996-08-15

ApplicantElan Pharma, Inc.
Decision Date1996-08-15
Product CodeCGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HICHEM CK/NAC REAGENT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Elan Pharma, Inc.. It received FDA 510(k) clearance on 1996-08-15 under 510(k) number K962247. 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 HICHEM CK/NAC REAGENT KIT?

HICHEM CK/NAC REAGENT KIT is a medical device that received FDA 510(k) clearance on 1996-08-15. The listed applicant is Elan Pharma, Inc.. The 510(k) number is K962247.

When did HICHEM CK/NAC REAGENT KIT receive FDA 510(k) clearance?

HICHEM CK/NAC REAGENT KIT received FDA 510(k) clearance on 1996-08-15, under 510(k) number K962247.

Who is the listed applicant for HICHEM CK/NAC REAGENT KIT?

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

What is the FDA product code for HICHEM CK/NAC REAGENT KIT?

The FDA product code for HICHEM CK/NAC REAGENT KIT is CGS.

Related Clinical Trials

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.

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Other records listing Elan Pharma, 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.

K982469HICHEM CHOLESTEROL REAGENT KITK981769HICHEM PHOSPHORUS REAGENT KITK960115HICHEM BUN/UREA REAGENT KIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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