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)

IMMUNOASSAY PLATE

K-Number: K812860 · 1981-10-26

ApplicantSkatron, Inc.
Decision Date1981-10-26
Product CodeJTC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNOASSAY PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Skatron, Inc.. It received FDA 510(k) clearance on 1981-10-26 under 510(k) number K812860. 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 IMMUNOASSAY PLATE?

IMMUNOASSAY PLATE is a medical device that received FDA 510(k) clearance on 1981-10-26. The listed applicant is Skatron, Inc.. The 510(k) number is K812860.

When did IMMUNOASSAY PLATE receive FDA 510(k) clearance?

IMMUNOASSAY PLATE received FDA 510(k) clearance on 1981-10-26, under 510(k) number K812860.

Who is the listed applicant for IMMUNOASSAY PLATE?

The FDA 510(k) record lists Skatron, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMUNOASSAY PLATE?

The FDA product code for IMMUNOASSAY PLATE 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 Skatron, 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.

K82196196 WELL DISPENSERK821034SKATRON REPEATING DISPENSERK820992MICROPLATE WASHING DEVICE

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.

↑