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)

ASSAY STRIPS

K-Number: K803244 · 1981-02-02

ApplicantCorning Costar Corp.
Decision Date1981-02-02
Product CodeJTC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ASSAY STRIPS is the device name listed in this FDA 510(k) record. The listed applicant is Corning Costar Corp.. It received FDA 510(k) clearance on 1981-02-02 under 510(k) number K803244. The device is classified under product code JTC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASSAY STRIPS?

ASSAY STRIPS is a medical device that received FDA 510(k) clearance on 1981-02-02. The listed applicant is Corning Costar Corp.. The 510(k) number is K803244.

When did ASSAY STRIPS receive FDA 510(k) clearance?

ASSAY STRIPS received FDA 510(k) clearance on 1981-02-02, under 510(k) number K803244.

Who is the listed applicant for ASSAY STRIPS?

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

What is the FDA product code for ASSAY STRIPS?

The FDA product code for ASSAY STRIPS is JTC.

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 Corning Costar 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.

K871559CELL LIFTERK860703U - STAR (MICRO-STAR)K823137OCTAPETTESK823138CELL SCRAPERK803242SEROCLUSTER EIA PLATESK803243SEROCLUSTER FLEXIBLE VINYL U & V PL.

View all 8 devices →

Related Devices (Code: JTC)

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.

K924907FILTERMATE UNIVERSAL HARVESTERPackard Instrument Co., Inc.K901808MICROMATE 196 MODEL A961960Packard Instrument Co., Inc.K894645IMMULON 1,2,3,AND 4 DIVIDASTRIPS TMDynatech Laboratories, Inc.K892369MULTI-PROBE HEAD PLUSHamilton Co.K891766GENETIC SYSTEMS MICROPLATE STRIP WASHERGenetic Systems Corp.K891765GENETIC SYSTEMS PIPETTOR/DILUTORGenetic Systems Corp.

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.

↑