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510(k) K862332

ANAEROBE RAPID CHROMOGENIC ID PANEL by American Micro Scan — Product Code JSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1986
Date Received
June 19, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Anaerobic Identification
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

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Other clearances for product code JSP

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  • K944528 — BBLCRYSTAL ANAEROBE ID SYSTEM (March 7, 1995)
  • K910666 — VITEK ANAEROBE IDENTIFICATION CARD, MODIFICATION (April 3, 1991)
  • K900996 — VITEK ANAEROBE IDENTIFICATION CARD (May 11, 1990)
  • K881380 — B. FRAGTEX (October 6, 1988)
  • K882960 — IDS RAPID ANA SYSTEM (August 12, 1988)
  • K855235 — DIAGNOSTIC REAGENT PET-RPLA (November 4, 1986)
  • K850052 — ANAEROBE KIT (March 5, 1985)