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FDA 510(k)

PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT

K-Number: K912231 · 1991-07-08

ApplicantIntl. Immunoassay Laboratories, Inc.
Decision Date1991-07-08
Product CodeJHW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Intl. Immunoassay Laboratories, Inc.. It received FDA 510(k) clearance on 1991-07-08 under 510(k) number K912231. The device is classified under product code JHW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT?

PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT is a medical device that received FDA 510(k) clearance on 1991-07-08. The listed applicant is Intl. Immunoassay Laboratories, Inc.. The 510(k) number is K912231.

When did PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT receive FDA 510(k) clearance?

PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT received FDA 510(k) clearance on 1991-07-08, under 510(k) number K912231.

Who is the listed applicant for PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT?

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

What is the FDA product code for PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT?

The FDA product code for PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KIT is JHW.

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Other records listing Intl. Immunoassay Laboratories, Inc. as applicant

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K913380MYDAS(TM)-MB2/MYDAS(TM)-MBK913349STAMBI-CKK903441MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTSK903508LABELLING CHANGES TO IMPRES-MB-XK901450MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MBK890609IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)

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Related Devices (Code: JHW)

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.

K162526Creatine Kinase-MBRoche DiagnosticsK122083ELITECH CLINICAL SYSTEMS CK NAC SLElitechgroupK023744WIENER LAB. CK-MB DS UV UNITEST, MODEL 28 X 2.5 ML CAT. NR. 1271354Wiener Laboratories SaicK003158ROCHE DIAGNOSTICS CK-MBRoche Diagnostics Corp.K961501ELECSYS CK-MBBoehringer Mannheim Corp.K950186CK-MB METHOD FOR THE TECHNICON IMMUNO 1(R) SYSTEM IN-VITRO DIAGNOSTIC SYSTEMMiles, 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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