Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ISOFOR-MM (TM)

K-Number: K883222 · 1988-09-30

ApplicantIntl. Immunoassay Laboratories, Inc.
Decision Date1988-09-30
Product CodeJHW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ISOFOR-MM (TM) 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 1988-09-30 under 510(k) number K883222. 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 ISOFOR-MM (TM)?

ISOFOR-MM (TM) is a medical device that received FDA 510(k) clearance on 1988-09-30. The listed applicant is Intl. Immunoassay Laboratories, Inc.. The 510(k) number is K883222.

When did ISOFOR-MM (TM) receive FDA 510(k) clearance?

ISOFOR-MM (TM) received FDA 510(k) clearance on 1988-09-30, under 510(k) number K883222.

Who is the listed applicant for ISOFOR-MM (TM)?

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 ISOFOR-MM (TM)?

The FDA product code for ISOFOR-MM (TM) is JHW.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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

View all 27 devices →

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.

↑