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510(k) K864249

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

K864249 is an FDA 510(k) premarket notification submitted by Mds Laboratories, Inc. for the device "NORMAL SALINE STERILE". The FDA issued a decision of Substantially Equivalent on March 31, 1987. The device falls under product code LIB (Device, General Purpose, Microbiology, Diagnostic), a Class I device regulated under 21 CFR 866.2660. Mds Laboratories, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K864244 — GARNERELLA VAGINALIS IDENTIFICATION KIT (March 31, 1987)
  • K864245 — MUELLER HINTON AGAR SMALL (March 31, 1987)
  • K864256 — TRYPTONE WATER (1%) (March 31, 1987)
  • K864243 — MACCONKEY AGAR (March 31, 1987)
  • K864239 — CLED AGAR WITH ANDRADES INDICATOR (March 31, 1987)
  • K864254 — THIOGLYCOLLATE BROTH (March 31, 1987)
  • K864252 — THAYER-MARTIN JEMBEC (March 31, 1987)
  • K864238 — CHOCOLATE AGAR (March 31, 1987)
  • K864242 — HEKTOEN ENTERIC AGAR (March 31, 1987)
  • K864246 — MUELLER HINTON AGAR LARGE (March 31, 1987)

Other clearances for product code LIB

  • K023677 — OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) (January 29, 2003)
  • 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)
  • K854602 — MINI MASH 2000 (December 6, 1985)
  • K854604 — AUTO MASH (December 6, 1985)
  • K854603 — MULTI MASH 2000 (December 6, 1985)

FDA data resources