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FDA 510(k)

SECONDARY CALIBRATORS

K-Number: K904335 · 1990-10-12

ApplicantBionostics, Inc.
Decision Date1990-10-12
Product CodeJGS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SECONDARY CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Bionostics, Inc.. It received FDA 510(k) clearance on 1990-10-12 under 510(k) number K904335. The device is classified under product code JGS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SECONDARY CALIBRATORS?

SECONDARY CALIBRATORS is a medical device that received FDA 510(k) clearance on 1990-10-12. The listed applicant is Bionostics, Inc.. The 510(k) number is K904335.

When did SECONDARY CALIBRATORS receive FDA 510(k) clearance?

SECONDARY CALIBRATORS received FDA 510(k) clearance on 1990-10-12, under 510(k) number K904335.

Who is the listed applicant for SECONDARY CALIBRATORS?

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 SECONDARY CALIBRATORS?

The FDA product code for SECONDARY CALIBRATORS is JGS.

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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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