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FDA 510(k)

MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL

K-Number: K031890 · 2003-07-16

ApplicantMedical Analysis Systems, Inc.
Decision Date2003-07-16
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL 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 2003-07-16 under 510(k) number K031890. 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 MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL?

MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL is a medical device that received FDA 510(k) clearance on 2003-07-16. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K031890.

When did MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL receive FDA 510(k) clearance?

MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL received FDA 510(k) clearance on 2003-07-16, under 510(k) number K031890.

Who is the listed applicant for MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL?

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 MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL?

The FDA product code for MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL is JJX.

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Other records listing Medical Analysis Systems, Inc. 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.

K042717MAS, DADE AND LIQUID ASSAYED DIABETES CONTROLK041194ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND HK040880MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3K032826MAS PAR TDMK032335MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TLK031441URICHEMTRAK LIQUID ASSAYED URINE CONTROL

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Related Devices (Code: JJX)

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.

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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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