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510(k) K972182

ABBOTT STREP A CONTROLS by Abbott Diagnostics — Product Code MJZ

K972182 is an FDA 510(k) premarket notification submitted by Abbott Diagnostics for the device "ABBOTT STREP A CONTROLS". The FDA issued a decision of Substantially Equivalent on August 13, 1997. The device falls under product code MJZ (Kit, Direct Antigen, Positive Control), a Class I device regulated under 21 CFR 862.1660. Abbott Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1997
Date Received
May 29, 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 Abbott Diagnostics

  • K964185 — IMX CA 125 (November 4, 1997)
  • K961439 — ABBOTT CELL-DYN 4000 SYSTEM (October 18, 1996)
  • K890491 — CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER (April 18, 1989)
  • K881242 — CELL-DYN RAPID-LYSE AND HEMOGLOBLIN (April 21, 1988)
  • K881130 — CELL-DYN ISOTONIC DILUENT (March 31, 1988)
  • K873347 — CELL-DYN DIFF. SCREEN ISOTONIC DILUENT (September 9, 1987)
  • K873348 — CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. (September 9, 1987)
  • K873408 — MODEL 690 SPECTROPHOTOMETER (September 8, 1987)
  • K872761 — CELL-DYN 610 HEMATOLOGY ANALYZER (August 6, 1987)
  • K870233 — CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER (March 17, 1987)

Other clearances for product code MJZ

  • K083744 — BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 (September 1, 2009)
  • K972129 — CHLAMYDIATROL AG (August 12, 1997)

FDA data resources