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510(k) K864239

CLED AGAR WITH ANDRADES INDICATOR by Mds Laboratories, Inc. — Product Code JSH

K864239 is an FDA 510(k) premarket notification submitted by Mds Laboratories, Inc. for the device "CLED AGAR WITH ANDRADES INDICATOR". The FDA issued a decision of Substantially Equivalent on March 31, 1987. The device falls under product code JSH (Culture Media, Non-Selective And Differential), a Class I device regulated under 21 CFR 866.2320. 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
Culture Media, Non-Selective And Differential
Device Class
Class I
Regulation Number
866.2320
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)
  • K864254 — THIOGLYCOLLATE BROTH (March 31, 1987)
  • K864252 — THAYER-MARTIN JEMBEC (March 31, 1987)
  • K864238 — CHOCOLATE AGAR (March 31, 1987)
  • K864249 — NORMAL SALINE STERILE (March 31, 1987)
  • K864242 — HEKTOEN ENTERIC AGAR (March 31, 1987)
  • K864246 — MUELLER HINTON AGAR LARGE (March 31, 1987)

Other clearances for product code JSH

  • K881486 — DNASE TEST AGAR (April 18, 1988)
  • K881560 — UREA BROTH (April 18, 1988)
  • K881553 — RUSSELL DOUBLE SUGAR AGAR (April 18, 1988)
  • K881551 — PHENOL RED BROTH BASE (April 18, 1988)
  • K881559 — UREA AGAR BASE (April 18, 1988)
  • K881540 — FLO AGAR (April 18, 1988)
  • K880121 — MOELLERS DECARBOXYLASE, BASE (March 31, 1988)
  • K880117 — OF MEDIUM BASE (March 30, 1988)
  • K873270 — ACTINOMYCETE DIFFERENTIAL MEDIA (November 4, 1987)
  • K873263 — MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA (October 28, 1987)

FDA data resources