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FDA 510(k)

DOCUMENT CK ISOENZYMES CONTROL

K-Number: K915792 · 1992-02-06

ApplicantCasco Standards
Decision Date1992-02-06
Product CodeCDP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DOCUMENT CK ISOENZYMES CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Casco Standards. It received FDA 510(k) clearance on 1992-02-06 under 510(k) number K915792. The device is classified under product code CDP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOCUMENT CK ISOENZYMES CONTROL?

DOCUMENT CK ISOENZYMES CONTROL is a medical device that received FDA 510(k) clearance on 1992-02-06. The listed applicant is Casco Standards. The 510(k) number is K915792.

When did DOCUMENT CK ISOENZYMES CONTROL receive FDA 510(k) clearance?

DOCUMENT CK ISOENZYMES CONTROL received FDA 510(k) clearance on 1992-02-06, under 510(k) number K915792.

Who is the listed applicant for DOCUMENT CK ISOENZYMES CONTROL?

The FDA 510(k) record lists Casco Standards as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DOCUMENT CK ISOENZYMES CONTROL?

The FDA product code for DOCUMENT CK ISOENZYMES CONTROL is CDP.

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Other records listing Casco Standards 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.

K981436DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109K972904DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROLK962629DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATORK961750DOCUMENT CARDIAC ASSAYED CONTROLK962630DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROLK960244DOCUMENT TDM ULTRA ASSAYED CONTROL

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Related Devices (Code: CDP)

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.

K001607REPROBEAD T3 ENZYME IMMUNOASSAY REAGENT KIT (CATALOG# 104)Repromedix Corp.K991692CHIRON DIAGNOSTICS ACS: 180 FT3Chiron Diagnostics Corp.K991311TOTAL T3 ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1005Biocheck, Inc.K991252AIA-PACK FT3 ASSAYTosoh Medics, Inc.K981824OPTICOAT T3 EIA KITBiotecx Laboratories, Inc.K983439ABBOTT ARCHITECT FREE T3Abbott Laboratories

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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