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FDA 510(k)

QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA

K-Number: K893896 · 1989-07-14

ApplicantBiostar Medical Products, Inc.
Decision Date1989-07-14
Product CodeLKJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA 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 1989-07-14 under 510(k) number K893896. 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 QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA?

QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is Biostar Medical Products, Inc.. The 510(k) number is K893896.

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

QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA received FDA 510(k) clearance on 1989-07-14, under 510(k) number K893896.

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

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 QUANTITATIVE ASSAY FOR DET. OF IGG IGM ANTI-DSDNA?

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

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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.

K893897SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGMK863238READS 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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