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FDA 510(k)

CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)

K-Number: K913133 · 1991-09-27

ApplicantBionostics, Inc.
Decision Date1991-09-27
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED) is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 1991-09-27 under 510(k) number K913133. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)?

CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED) is a medical device that received FDA 510(k) clearance on 1991-09-27. The listed applicant is Bionostics, Inc.. The 510(k) number is K913133.

When did CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED) receive FDA 510(k) clearance?

CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED) received FDA 510(k) clearance on 1991-09-27, under 510(k) number K913133.

Who is the listed applicant for CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)?

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

What is the FDA product code for CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)?

The FDA product code for CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED) is JJY.

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Other records listing Bionostics, Inc. as applicant

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Related Devices (Code: JJY)

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.

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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.

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