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FDA 510(k)

MYCOPLASMA DETECTION KIT

K-Number: K771867 · 1977-11-17

ApplicantBioassay Systems Research Corp.
Decision Date1977-11-17
Product CodeKPB
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MYCOPLASMA DETECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bioassay Systems Research Corp.. It received FDA 510(k) clearance on 1977-11-17 under 510(k) number K771867. The device is classified under product code KPB. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MYCOPLASMA DETECTION KIT?

MYCOPLASMA DETECTION KIT is a medical device that received FDA 510(k) clearance on 1977-11-17. The listed applicant is Bioassay Systems Research Corp.. The 510(k) number is K771867.

When did MYCOPLASMA DETECTION KIT receive FDA 510(k) clearance?

MYCOPLASMA DETECTION KIT received FDA 510(k) clearance on 1977-11-17, under 510(k) number K771867.

Who is the listed applicant for MYCOPLASMA DETECTION KIT?

The FDA 510(k) record lists Bioassay Systems Research Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MYCOPLASMA DETECTION KIT?

The FDA product code for MYCOPLASMA DETECTION KIT is KPB.

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 Bioassay Systems Research Corp. 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.

K850990HFF GENCELLSK780869CELL CULTURE LINES

Related Devices (Code: KPB)

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.

K781875STAIN KIT FOR CELL CULTURES (30-100-00)Flow Laboratories, Inc.K781874MYCOPLASMA ARGININI FITC (30-403-41)Flow Laboratories, Inc.K781390MYCOPLASMA HYORHINIS (BTS-7)Flow 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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