FDA 510(k)

CHALLENGE (TM) LIQ THERA DRUG CONTROLS

K-Number: K910333 · 1991-04-12

Decision Date1991-04-12

Product CodeDIF

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

CHALLENGE (TM) LIQ THERA DRUG CONTROLS 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 1991-04-12 under 510(k) number K910333. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHALLENGE (TM) LIQ THERA DRUG CONTROLS?

CHALLENGE (TM) LIQ THERA DRUG CONTROLS is a medical device that received FDA 510(k) clearance on 1991-04-12. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K910333.

When did CHALLENGE (TM) LIQ THERA DRUG CONTROLS receive FDA 510(k) clearance?

CHALLENGE (TM) LIQ THERA DRUG CONTROLS received FDA 510(k) clearance on 1991-04-12, under 510(k) number K910333.

Who is the listed applicant for CHALLENGE (TM) LIQ THERA DRUG CONTROLS?

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 CHALLENGE (TM) LIQ THERA DRUG CONTROLS?

The FDA product code for CHALLENGE (TM) LIQ THERA DRUG CONTROLS is DIF.

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Other records listing Medical Analysis Systems, Inc. as applicant

K042717MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL K041194ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H K040880MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 K032826MAS PAR TDM K032335MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL K031890MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL

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Related Devices (Code: DIF)

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.