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FDA 510(k)

BILIRUBIN CALIBRATOR #65071

K-Number: K822479 · 1982-09-14

ApplicantEmd Chemicals, Inc.
Decision Date1982-09-14
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BILIRUBIN CALIBRATOR #65071 is the device name listed in this FDA 510(k) record. The listed applicant is Emd Chemicals, Inc.. It received FDA 510(k) clearance on 1982-09-14 under 510(k) number K822479. The device is classified under product code JIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BILIRUBIN CALIBRATOR #65071?

BILIRUBIN CALIBRATOR #65071 is a medical device that received FDA 510(k) clearance on 1982-09-14. The listed applicant is Emd Chemicals, Inc.. The 510(k) number is K822479.

When did BILIRUBIN CALIBRATOR #65071 receive FDA 510(k) clearance?

BILIRUBIN CALIBRATOR #65071 received FDA 510(k) clearance on 1982-09-14, under 510(k) number K822479.

Who is the listed applicant for BILIRUBIN CALIBRATOR #65071?

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

What is the FDA product code for BILIRUBIN CALIBRATOR #65071?

The FDA product code for BILIRUBIN CALIBRATOR #65071 is JIT.

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Other records listing Emd Chemicals, Inc. as applicant

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Related Devices (Code: JIT)

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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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