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FDA 510(k)

MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB

K-Number: K901450 · 1990-05-15

ApplicantIntl. Immunoassay Laboratories, Inc.
Decision Date1990-05-15
Product CodeJHT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB 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 1990-05-15 under 510(k) number K901450. 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 MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB?

MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB is a medical device that received FDA 510(k) clearance on 1990-05-15. The listed applicant is Intl. Immunoassay Laboratories, Inc.. The 510(k) number is K901450.

When did MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB receive FDA 510(k) clearance?

MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB received FDA 510(k) clearance on 1990-05-15, under 510(k) number K901450.

Who is the listed applicant for MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB?

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 MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB?

The FDA product code for MODIFIED LABEL FOR EMBRIA-CK, QUICK-MB/MICROMI-MB 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-XK890609IMPRES-MB (ADDITION OF AN OPTIONAL TEST PROCEDURE)

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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.K896170REP CK ISOFORMS KIT CAT. NO. 3081, 3082, 3083Helena 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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