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510(k) K864249

NORMAL SALINE STERILE by Mds Laboratories, Inc. — Product Code LIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1987
Date Received
October 28, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, General Purpose, Microbiology, Diagnostic
Device Class
Class I
Regulation Number
866.2660
Review Panel
MI
Submission Type

Other clearances by Mds Laboratories, Inc.

  • K864251 — SELENITE F. BROTH (March 31, 1987)
  • K864240 — COLUMBIA BLOOD AGAR WITH 5% SHEEP BLOOD (March 31, 1987)
  • K864237 — CARY BLAIR TRANSPORT MEDIUM (March 31, 1987)
  • K864253 — THAYER MARTIN AGAR (March 31, 1987)
  • K864248 — MUELLER HINTON AGAR - SUPPLEMENTED (March 31, 1987)
  • K864246 — MUELLER HINTON AGAR LARGE (March 31, 1987)
  • K864256 — TRYPTONE WATER (1%) (March 31, 1987)
  • K864241 — DNASE AGAR (March 31, 1987)
  • K864245 — MUELLER HINTON AGAR SMALL (March 31, 1987)
  • K864247 — MUELLER HINTON AGAR WITH 5% SHEEP BLOOD (March 31, 1987)

Other clearances for product code LIB

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  • K920416 — SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB (April 8, 1992)
  • K912558 — GULL ELISAWARE (September 16, 1991)
  • K872273 — CORNING EASY WASH ELISA PLATES (July 7, 1987)
  • K871559 — CELL LIFTER (May 15, 1987)
  • K863789 — CORNING ELISA PLATES (October 3, 1986)
  • K862112 — MICROSCOPE SLIDES (June 13, 1986)
  • K854604 — AUTO MASH (December 6, 1985)
  • K854602 — MINI MASH 2000 (December 6, 1985)
  • K854603 — MULTI MASH 2000 (December 6, 1985)