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510(k) K852613

MIC-CONCEPT SYSTEM by Microtech Medical Systems, Inc. — Product Code LTW

K852613 is an FDA 510(k) premarket notification submitted by Microtech Medical Systems, Inc. for the device "MIC-CONCEPT SYSTEM". The FDA issued a decision of Substantially Equivalent on September 20, 1985. The device falls under product code LTW (Susceptibility Test Cards, Antimicrobial), a Class II device regulated under 21 CFR 866.1640. Microtech Medical Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 20, 1985
Date Received
June 19, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Cards, Antimicrobial
Device Class
Class II
Regulation Number
866.1640
Review Panel
MI
Submission Type

Other clearances by Microtech Medical Systems, Inc.

  • K935485 — FAS FASTIDIOUS MIC PANEL (February 16, 1995)
  • K901598 — FASTIDIOUS MIC PANEL (November 8, 1990)
  • K896332 — SUPPLEMENT TO ANAEROBIC MIC PANEL (February 5, 1990)
  • K884831 — ANAEROBIC MIC PANEL (March 27, 1989)
  • K863847 — MIC - CONCEPT(TM) RX-2 (December 18, 1986)
  • K861774 — QUADRA-TITER (TM) I.D. (MODIFICATION) (May 20, 1986)
  • K860208 — QUADRA-TITER I.D. (March 3, 1986)
  • K853745 — MIC-CONCEPT VIEWBOX (September 19, 1985)
  • K850725 — QUADRA TITER MICRO PLATES (April 30, 1985)
  • K851020 — MIC-CONCEPT INOCULATOR (March 29, 1985)

Other clearances for product code LTW

  • K853273 — PRECEPT CEFTRIAXONE (September 16, 1985)
  • K853772 — PRECEPT METHICILLIN (September 16, 1985)
  • K853685 — PRECEPT TM CARBENICILLIN (September 16, 1985)
  • K853596 — PRECEPT CEFOPERAZONE (September 16, 1985)
  • K853689 — PRECEPT TM MOXALACTAM (September 13, 1985)
  • K853684 — PRECEPT KANAMYCIN (September 13, 1985)
  • K853686 — PRECEPT TM AMIKACIN (September 13, 1985)
  • K853688 — PRECEPT TM TOBRAMYCIN (September 13, 1985)
  • K853687 — PRECEPT NETILMICIN 32-13 (September 13, 1985)
  • K853263 — PRECEPT AVGMENTIN (August 29, 1985)

FDA data resources