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FDA 510(k)

SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3

K-Number: K944999 · 1995-06-06

ApplicantMore Diagnostics
Decision Date1995-06-06
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3 is the device name listed in this FDA 510(k) record. The listed applicant is More Diagnostics. It received FDA 510(k) clearance on 1995-06-06 under 510(k) number K944999. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3?

SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3 is a medical device that received FDA 510(k) clearance on 1995-06-06. The listed applicant is More Diagnostics. The 510(k) number is K944999.

When did SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3 receive FDA 510(k) clearance?

SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3 received FDA 510(k) clearance on 1995-06-06, under 510(k) number K944999.

Who is the listed applicant for SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3?

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

What is the FDA product code for SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3?

The FDA product code for SERUM BILIRUBIN CONTROL- LEVEL 1, 2 AND 3 is JJX.

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Other records listing More Diagnostics as applicant

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.

K072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELK050125RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4K982845CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3K980331IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\SK972976CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVELK970778LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4

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Related Devices (Code: JJX)

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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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