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510(k) K864238

CHOCOLATE AGAR by Mds Laboratories, Inc. — Product Code KZI

K864238 is an FDA 510(k) premarket notification submitted by Mds Laboratories, Inc. for the device "CHOCOLATE AGAR". The FDA issued a decision of Substantially Equivalent on March 31, 1987. The device falls under product code KZI (Culture Media, Enriched), a Class I device regulated under 21 CFR 866.2330. 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, Enriched
Device Class
Class I
Regulation Number
866.2330
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)
  • 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 KZI

  • K884208 — LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) (October 25, 1988)
  • K881995 — DIAMOND'S MEDIUM MODIFIED (June 2, 1988)
  • K880134 — MIDDLEBROOK 7H11 AGAR (March 31, 1988)
  • K880131 — LOWENSTEIN-JENSEN, GRUFT (March 31, 1988)
  • K880122 — MIDDLEBROOK 7H9 BROTH (March 31, 1988)
  • K880109 — CYSTINE TRYPTIC MEDIUM BASE (March 30, 1988)
  • K880138 — WALLENSTEIN MEDIUM SLANT (March 30, 1988)
  • K880127 — POTATO DEXTROSE AGAR (March 7, 1988)
  • K874179 — BIOTIS (TM) SABHI (DOUBLE POUR) (January 28, 1988)
  • K874177 — BIOTIS (TM) BCYE (December 4, 1987)

FDA data resources