Chlamydiatrol AG

FDA 510(k) K972129 · Blackhawk Biosystems, Inc.

Substantially Equivalent

510(k) numberK972129

Submission

Device name
Chlamydiatrol AG
Applicant
Blackhawk Biosystems, Inc.
San Ramon, CA, US
Received
June 6, 1997
Decision date
August 12, 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

Other 510(k)s with product code MJZ

510(k)DeviceApplicantDecision
K083744Binaxnow Malaria Positive Control Kit, Model 665-010MJZ · Traditional Binax, Inc.09/01/2009SE
K972182Abbott Strep a ControlsMJZ · Traditional Abbott Diagnostics08/13/1997SE

More from Abbott Diagnostics

510(k)DeviceDecision
K974613Virotrol IIIJJY · Traditional 01/27/1998SE
K954298Virotrol IVJJY · Traditional 11/01/1995SE
K942295Virotrol TorchJJY · Traditional 10/07/1994SE

Questions and answers

When was Chlamydiatrol AG cleared by the FDA?

Chlamydiatrol AG (K972129) received a 510(k) decision of Substantially Equivalent on August 12, 1997, 67 days after the submission was received.

What is the product code of K972129?

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