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FDA 510(k)

125I QUICK-MB TEST KIT FOR QUANTITATION

K-Number: K821964 · 1982-07-22

ApplicantIntl. Immunoassay Laboratories, Inc.
Decision Date1982-07-22
Product CodeJHT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

125I QUICK-MB TEST KIT FOR QUANTITATION 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 1982-07-22 under 510(k) number K821964. 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 125I QUICK-MB TEST KIT FOR QUANTITATION?

125I QUICK-MB TEST KIT FOR QUANTITATION is a medical device that received FDA 510(k) clearance on 1982-07-22. The listed applicant is Intl. Immunoassay Laboratories, Inc.. The 510(k) number is K821964.

When did 125I QUICK-MB TEST KIT FOR QUANTITATION receive FDA 510(k) clearance?

125I QUICK-MB TEST KIT FOR QUANTITATION received FDA 510(k) clearance on 1982-07-22, under 510(k) number K821964.

Who is the listed applicant for 125I QUICK-MB TEST KIT FOR QUANTITATION?

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 125I QUICK-MB TEST KIT FOR QUANTITATION?

The FDA product code for 125I QUICK-MB TEST KIT FOR QUANTITATION is JHT.

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Other records listing Intl. Immunoassay Laboratories, 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.

K913380MYDAS(TM)-MB2/MYDAS(TM)-MBK913349STAMBI-CKK912231PROPOSED NEW USE OF INSTRUMENT SYSTEM AND TEST KITK903441MYDAS(TM) BRAND SOLID-PHASE ANTIBODY REAGENTSK903508LABELLING CHANGES TO IMPRES-MB-XK901450MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB

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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 LaboratoriesK904721DSL CK-MB (DSL #3200)Diagnostic Systems Laboratories, Inc.K904866COULTER CK-MB ISOENZYME REAGENTCoulter Electronics, 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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