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)

HFF GENCELLS

K-Number: K850990 · 1985-04-12

ApplicantBioassay Systems Research Corp.
Decision Date1985-04-12
Product CodeKIT
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HFF GENCELLS 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 1985-04-12 under 510(k) number K850990. The device is classified under product code KIT. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HFF GENCELLS?

HFF GENCELLS is a medical device that received FDA 510(k) clearance on 1985-04-12. The listed applicant is Bioassay Systems Research Corp.. The 510(k) number is K850990.

When did HFF GENCELLS receive FDA 510(k) clearance?

HFF GENCELLS received FDA 510(k) clearance on 1985-04-12, under 510(k) number K850990.

Who is the listed applicant for HFF GENCELLS?

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 HFF GENCELLS?

The FDA product code for HFF GENCELLS is KIT.

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.

K780869CELL CULTURE LINESK771867MYCOPLASMA DETECTION KIT

Related Devices (Code: KIT)

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.

K892938AMNIO-GROW TMInovar Biologicals, Inc.K890700MELANOCYTE GROWTH MEDIUM (MGM)Clonetics Corp.K890701ENDOTHELIAL GROWTH MEDIUM (EGM)Clonetics Corp.K890482ABC, ABC-1X, ABC(TM)Cell Ent., Inc.K884654ALPHACALF SERUMHyclone Laboratories, Inc.K884572RPMI-1640 HYBRI-MAX, PROD. NO. R5382Sigma Chemical Co.

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.

↑