FDA 510(k)

TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3

K-Number: K993546 · 1999-11-30

Decision Date1999-11-30

Product CodeJJY

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3 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 1999-11-30 under 510(k) number K993546. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3?

TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3 is a medical device that received FDA 510(k) clearance on 1999-11-30. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K993546.

When did TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3 receive FDA 510(k) clearance?

TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3 received FDA 510(k) clearance on 1999-11-30, under 510(k) number K993546.

Who is the listed applicant for TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3?

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 TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3?

The FDA product code for TRI-POINT, LIQUIMMUNE LIQUID ASSAYED IMMUNOASSAY CONTROL, LEVELS 1, 2, AND 3 is JJY.

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Other records listing Medical Analysis Systems, Inc. as applicant

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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.