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FDA 510(k)

SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM

K-Number: K893897 · 1989-06-23

ApplicantBiostar Medical Products, Inc.
Decision Date1989-06-23
Product CodeLKJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM is the device name listed in this FDA 510(k) record. The listed applicant is Biostar Medical Products, Inc.. It received FDA 510(k) clearance on 1989-06-23 under 510(k) number K893897. The device is classified under product code LKJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM?

SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM is a medical device that received FDA 510(k) clearance on 1989-06-23. The listed applicant is Biostar Medical Products, Inc.. The 510(k) number is K893897.

When did SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM receive FDA 510(k) clearance?

SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM received FDA 510(k) clearance on 1989-06-23, under 510(k) number K893897.

Who is the listed applicant for SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM?

The FDA 510(k) record lists Biostar Medical Products, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM?

The FDA product code for SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGM is LKJ.

Related Clinical Trials

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Other records listing Biostar Medical Products, 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.

K893896QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNAK863238READS RF TEST KIT FOR IGM RHEUMATOID FACTORK861499BIOSTAR* READS* IMMUNE COMPLEX ASSAY KITK853697BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT

Related Devices (Code: LKJ)

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.

K210902EliA Ro52, EliA Ro60Phadia ABK113610ANA-SCREEN WITH MDSSBio-Rad LaboratoriesK082759ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAYPhadia US, Inc.K081104AESKULISA ANA HEP-2, REF 30-7115USAesku DiagnosticsK041658BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200Bio-Rad Laboratories, Inc.K042416ATHENA MULTI-LYTE ANA-II TEST SYSTEMZeus Scientific, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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