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)

MODEL 80 BC

K-Number: K821414 · 1982-05-27

Decision Date1982-05-27
Product Code
DecisionSubstantially Equivalent

Device Summary

MODEL 80 BC is the device name listed in this FDA 510(k) record. The listed applicant is Western Laboratories Corp.. It received FDA 510(k) clearance on 1982-05-27 under 510(k) number K821414. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 80 BC?

MODEL 80 BC is a medical device that received FDA 510(k) clearance on 1982-05-27. The listed applicant is Western Laboratories Corp.. The 510(k) number is K821414.

When did MODEL 80 BC receive FDA 510(k) clearance?

MODEL 80 BC received FDA 510(k) clearance on 1982-05-27, under 510(k) number K821414.

Who is the listed applicant for MODEL 80 BC?

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

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.

Other records listing Western Laboratories 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.

View all 7 devices →

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.

↑