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FDA 510(k)

DIRECT BILIRUBEN CALIBRATIONS

K-Number: K852067 · 1985-05-31

ApplicantData Medical Associates, Inc.
Decision Date1985-05-31
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT BILIRUBEN CALIBRATIONS is the device name listed in this FDA 510(k) record. The listed applicant is Data Medical Associates, Inc.. It received FDA 510(k) clearance on 1985-05-31 under 510(k) number K852067. 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 DIRECT BILIRUBEN CALIBRATIONS?

DIRECT BILIRUBEN CALIBRATIONS is a medical device that received FDA 510(k) clearance on 1985-05-31. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K852067.

When did DIRECT BILIRUBEN CALIBRATIONS receive FDA 510(k) clearance?

DIRECT BILIRUBEN CALIBRATIONS received FDA 510(k) clearance on 1985-05-31, under 510(k) number K852067.

Who is the listed applicant for DIRECT BILIRUBEN CALIBRATIONS?

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

What is the FDA product code for DIRECT BILIRUBEN CALIBRATIONS?

The FDA product code for DIRECT BILIRUBEN CALIBRATIONS is 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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