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FDA 510(k)

BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT

K-Number: K853697 · 1985-12-16

ApplicantBiostar Medical Products, Inc.
Decision Date1985-12-16
Product CodeDAK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT 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 1985-12-16 under 510(k) number K853697. The device is classified under product code DAK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT?

BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT is a medical device that received FDA 510(k) clearance on 1985-12-16. The listed applicant is Biostar Medical Products, Inc.. The 510(k) number is K853697.

When did BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT receive FDA 510(k) clearance?

BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT received FDA 510(k) clearance on 1985-12-16, under 510(k) number K853697.

Who is the listed applicant for BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT?

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 BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT?

The FDA product code for BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT is DAK.

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.

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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-DSDNAK893897SEMI-QUANTITATIVE ASSAY FOR DET. OF IGG AND IGMK863238READS RF TEST KIT FOR IGM RHEUMATOID FACTORK861499BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT

Related Devices (Code: DAK)

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.

K031563BINDAZYME CLQ CIC EIA KITThe Binding Site, Ltd.K032254IBL C1Q-CIC CIA TESTIbl GmbHK012576CIC-C1Q EIAAmerican Laboratory Products Co., Ltd.K973203THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODIESSangstat Medical Corp.K972873IMMUSTRIP HAMA IGGImmunomedics, Inc.K951968HUMAN C1Q RADIAL IMMUNODIFFUSION KITKent Laboratories, 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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