FDA 510(k)

BIO-CAL OPERATION CHECK KIT

K-Number: K821934 · 1982-07-20

ApplicantBio-Analytics Laboratories, Inc.

Decision Date1982-07-20

Product CodeJIS

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

BIO-CAL OPERATION CHECK KIT is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Analytics Laboratories, Inc.. It received FDA 510(k) clearance on 1982-07-20 under 510(k) number K821934. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-CAL OPERATION CHECK KIT?

BIO-CAL OPERATION CHECK KIT is a medical device that received FDA 510(k) clearance on 1982-07-20. The listed applicant is Bio-Analytics Laboratories, Inc.. The 510(k) number is K821934.

When did BIO-CAL OPERATION CHECK KIT receive FDA 510(k) clearance?

BIO-CAL OPERATION CHECK KIT received FDA 510(k) clearance on 1982-07-20, under 510(k) number K821934.

Who is the listed applicant for BIO-CAL OPERATION CHECK KIT?

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

What is the FDA product code for BIO-CAL OPERATION CHECK KIT?

The FDA product code for BIO-CAL OPERATION CHECK KIT is JIS.

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Other records listing Bio-Analytics Laboratories, Inc. as applicant

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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.