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510(k) K945488

LYFO(TM) DIFFERENTIAL DISK by Microbiologics, Inc. — Product Code JSP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 11, 1995
Date Received
November 8, 1994
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

  • K945487 — LYFO(TM) DIFFERENTIAL DISK (May 11, 1995)
  • K945489 — 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)
  • K862332 — ANAEROBE RAPID CHROMOGENIC ID PANEL (August 27, 1986)
  • K850052 — ANAEROBE KIT (March 5, 1985)