THE STAGO VIII DEFICIENT PLASMA KIT— 510(k) K892859

Clearance details

Applicant

American Bioproducts Co.

Product code

Code GGP

Device class

Class 2

Regulation

21 CFR 864.7290

Advisory panel

Hematology

Date received

1989-04-18

Decision date

1989-06-23

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Parsippany, NJ, US

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• Z-1699-2020 — STA - Deficient VIII, Product Code: 00725. STA - Deficient VIII is an immuno-depleted human plasma intended for use in tests for the determination of factor VIII activity in plasma on STA-R and STA Compact analyzer platforms as follows: (A) STA-R Max, Product Codes: 58989, 58990 (B) STA-R Evolution, Product Codes: 58986, 58987, 58988 (C) STA Compact Max, Product Codes: 59026, 59027 (D) STA Compact, Product Codes: 58978, 58979Class II·Terminated·Diagnostica Stago, Inc.·20200304

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K892859.