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510(k) K023889

WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254 by Wiener Laboratories Saic — Product Code MIU

K023889 is an FDA 510(k) premarket notification submitted by Wiener Laboratories Saic for the device "WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 1203254". The FDA issued a decision of Substantially Equivalent on February 11, 2004. The device falls under product code MIU (Enzyme Linked Immunosorbent Assay, T. Cruzi), a Class I device regulated under 21 CFR 866.3870. Wiener Laboratories Saic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 11, 2004
Date Received: November 21, 2002
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Enzyme Linked Immunosorbent Assay, T. Cruzi
Device Class: Class I
Regulation Number: 866.3870
Review Panel: MI
Submission Type

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K023549 — WIENER LAB AMILASA 405 AA LIQUIDA (December 9, 2002)
K023551 — WIENER LAB GOT (AST) UV AA LIQUIDA (December 9, 2002)
K023550 — WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA (December 9, 2002)
K022962 — WIENER LAB. BILIRRUBINA TOTAL AA (November 1, 2002)
K021334 — WIENER LAB. CA-COLOR ARSENAZO III AA, MODEL 4X50 ML CAT.NR. 1152004, WIENER LAB. (September 10, 2002)
K021332 — WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV A (July 3, 2002)

510(k) K023889

Clearance Details

Device Classification

Other clearances by Wiener Laboratories Saic

Other clearances for product code MIU

FDA data resources