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510(k) K862332

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

K862332 is an FDA 510(k) premarket notification submitted by American Micro Scan for the device "ANAEROBE RAPID CHROMOGENIC ID PANEL". The FDA issued a decision of Substantially Equivalent on August 27, 1986. The device falls under product code JSP (Kit, Anaerobic Identification), a Class I device regulated under 21 CFR 866.2660. American Micro Scan has at least 10 other 510(k) clearances on record.

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

Other clearances by American Micro Scan

  • K870029 — IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE (March 25, 1987)
  • K864662 — CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS (March 25, 1987)
  • K863776 — MICRODILUTION MIC PANELS (February 2, 1987)
  • K864674 — MICRODILUTION IDENTIFICATION PANELS (January 5, 1987)
  • K864389 — CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST (December 4, 1986)
  • K863038 — GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL (September 30, 1986)
  • K862642 — GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL (September 11, 1986)
  • K862140 — MICRODILUTION PANELS (July 16, 1986)
  • K861584 — GRAM NEGATIVE COMBO PANEL TYPE 3 (June 17, 1986)
  • K860575 — YEAST IDENTIFICATION PANEL (May 13, 1986)

Other clearances for product code JSP

  • K945489 — LYFO(TM) DIFFERENTIAL DISK (May 11, 1995)
  • K945488 — LYFO(TM) DIFFERENTIAL DISK (May 11, 1995)
  • K945487 — LYFO(TM) DIFFERENTIAL DISK (May 11, 1995)
  • 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)

FDA data resources