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FDA 510(k)

AMER. BIO-SCIENCE LAB CORTISOL REAGENT

K-Number: K842455 · 1984-08-16

ApplicantAmerican Bio-Science Laboratories
Decision Date1984-08-16
Product CodeCGR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMER. BIO-SCIENCE LAB CORTISOL REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is American Bio-Science Laboratories. It received FDA 510(k) clearance on 1984-08-16 under 510(k) number K842455. The device is classified under product code CGR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMER. BIO-SCIENCE LAB CORTISOL REAGENT?

AMER. BIO-SCIENCE LAB CORTISOL REAGENT is a medical device that received FDA 510(k) clearance on 1984-08-16. The listed applicant is American Bio-Science Laboratories. The 510(k) number is K842455.

When did AMER. BIO-SCIENCE LAB CORTISOL REAGENT receive FDA 510(k) clearance?

AMER. BIO-SCIENCE LAB CORTISOL REAGENT received FDA 510(k) clearance on 1984-08-16, under 510(k) number K842455.

Who is the listed applicant for AMER. BIO-SCIENCE LAB CORTISOL REAGENT?

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

What is the FDA product code for AMER. BIO-SCIENCE LAB CORTISOL REAGENT?

The FDA product code for AMER. BIO-SCIENCE LAB CORTISOL REAGENT is CGR.

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Other records listing American Bio-Science Laboratories 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.

K842590AMER. BIO-SCIENCE LAB T3 REAGENTS

Related Devices (Code: CGR)

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Official Source

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