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510(k) K972129

CHLAMYDIATROL AG by Blackhawk Biosystems, Inc. — Product Code MJZ

K972129 is an FDA 510(k) premarket notification submitted by Blackhawk Biosystems, Inc. for the device "CHLAMYDIATROL AG". The FDA issued a decision of Substantially Equivalent on August 12, 1997. The device falls under product code MJZ (Kit, Direct Antigen, Positive Control), a Class I device regulated under 21 CFR 862.1660. Blackhawk Biosystems, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1997
Date Received
June 6, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Direct Antigen, Positive Control
Device Class
Class I
Regulation Number
862.1660
Review Panel
MI
Submission Type

Other clearances by Blackhawk Biosystems, Inc.

  • K974613 — VIROTROL III (January 27, 1998)
  • K954298 — VIROTROL IV (November 1, 1995)
  • K942295 — VIROTROL TORCH (October 7, 1994)

Other clearances for product code MJZ

  • K083744 — BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 (September 1, 2009)
  • K972182 — ABBOTT STREP A CONTROLS (August 13, 1997)

FDA data resources