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FDA 510(k)

CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/

K-Number: K851670 · 1985-05-10

ApplicantMedical Analysis Systems, Inc.
Decision Date1985-05-10
Product CodeJIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/ is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 1985-05-10 under 510(k) number K851670. 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 CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/?

CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/ is a medical device that received FDA 510(k) clearance on 1985-05-10. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K851670.

When did CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/ receive FDA 510(k) clearance?

CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/ received FDA 510(k) clearance on 1985-05-10, under 510(k) number K851670.

Who is the listed applicant for CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/?

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

What is the FDA product code for CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/?

The FDA product code for CHEM TRAK TRI-POINT LIQUID BILIRUBIN CALIBRATOR,I/ is JIT.

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Other records listing Medical Analysis Systems, 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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