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FDA 510(k)

SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM

K-Number: K874284 · 1988-01-21

ApplicantDiagnostic Chemicals, Ltd. (Usa)
Decision Date1988-01-21
Product CodeJHT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). It received FDA 510(k) clearance on 1988-01-21 under 510(k) number K874284. The device is classified under product code JHT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM?

SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM is a medical device that received FDA 510(k) clearance on 1988-01-21. The listed applicant is Diagnostic Chemicals, Ltd. (Usa). The 510(k) number is K874284.

When did SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM receive FDA 510(k) clearance?

SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM received FDA 510(k) clearance on 1988-01-21, under 510(k) number K874284.

Who is the listed applicant for SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM?

The FDA 510(k) record lists Diagnostic Chemicals, Ltd. (Usa) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM?

The FDA product code for SHOT-GUN ISOLAT PROCED/MEASUREMENT CK-MB IN SERUM is JHT.

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Other records listing Diagnostic Chemicals, Ltd. (Usa) 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.

K022538IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25K974874BILIRUBIN-SL (TOTAL) ASSAYK932556AMMONIA ASSAY CAT. NO. 200-02K932766HDL-CHOLESTRAL(DEXTRAN SULFATE/MAGNESIUM)K932555DC-LINEATE CAT. NO. SE-091K925877DC-UIBC-CAL

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Related Devices (Code: JHT)

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.

K022409SPECTRAL'S CARDIAC STATUS CK-MB RAPID TESTSpectral Diagnostics, Inc.K991299MODIFICATION TO CARDIAC STATUS CK-MB/MYOGLOBIN RAPID ONE-STEP TEST, LIFESIGN MI CK-MB/MYOGLOBIN, LIFESIGN CK-MB/MYOGLOBIPrinceton BioMeditech Corp.K930359CARDIO REP-CAT. NO. 1400 & CK ISOFORMS KIT 3305Helena LaboratoriesK904866COULTER CK-MB ISOENZYME REAGENTCoulter Electronics, Inc.K904721DSL CK-MB (DSL #3200)Diagnostic Systems Laboratories, Inc.K901450MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MBIntl. Immunoassay Laboratories, 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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