Abbott Strep a Controls

FDA 510(k) K972182 · Abbott Diagnostics

Substantially Equivalent

510(k) numberK972182

Submission

Device name
Abbott Strep a Controls
Applicant
Abbott Diagnostics
Abbott Park, IL, US
Received
May 29, 1997
Decision date
August 13, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MJZ – Kit, Direct Antigen, Positive Control
Device class
Class I (low risk)
Regulation
21 CFR 862.1660
Specialty
Clinical Chemistry

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K083744Binaxnow Malaria Positive Control Kit, Model 665-010MJZ · Traditional Binax, Inc.09/01/2009SE
K972129Chlamydiatrol AGMJZ · Traditional Blackhawk Biosystems, Inc.08/12/1997SE

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K881130Cell-Dyn Isotonic DiluentGIF · Traditional 03/31/1988SE
K873348Cell-Dyn Diff Screen, Auto. & Semi Auto. Lytic Ag.GGK · Traditional 09/09/1987SE
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K873408Model 690 SpectrophotometerJJQ · Traditional 09/08/1987SE
K872761Cell-Dyn 610 Hematology AnalyzerGKZ · Traditional 08/06/1987SE
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Questions and answers

When was Abbott Strep a Controls cleared by the FDA?

Abbott Strep a Controls (K972182) received a 510(k) decision of Substantially Equivalent on August 13, 1997, 76 days after the submission was received.

What is the product code of K972182?

The FDA product code is MJZ – Kit, Direct Antigen, Positive Control, a Class I (low risk) device regulated under 21 CFR 862.1660.