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510(k) K864240

COLUMBIA BLOOD AGAR WITH 5% SHEEP BLOOD by Mds Laboratories, Inc. — Product Code JSG

K864240 is an FDA 510(k) premarket notification submitted by Mds Laboratories, Inc. for the device "COLUMBIA BLOOD AGAR WITH 5% SHEEP BLOOD". The FDA issued a decision of Substantially Equivalent on March 31, 1987. The device falls under product code JSG (Culture Media, Non-Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2300. 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 Non-Differential
Device Class
Class I
Regulation Number
866.2300
Review Panel
MI
Submission Type

Other clearances by Mds Laboratories, Inc.

  • K864244 — GARNERELLA VAGINALIS IDENTIFICATION KIT (March 31, 1987)
  • K864239 — CLED AGAR WITH ANDRADES INDICATOR (March 31, 1987)
  • K864254 — THIOGLYCOLLATE BROTH (March 31, 1987)
  • K864238 — CHOCOLATE AGAR (March 31, 1987)
  • K864248 — MUELLER HINTON AGAR - SUPPLEMENTED (March 31, 1987)
  • K864245 — MUELLER HINTON AGAR SMALL (March 31, 1987)
  • K864242 — HEKTOEN ENTERIC AGAR (March 31, 1987)
  • K864243 — MACCONKEY AGAR (March 31, 1987)
  • K864252 — THAYER-MARTIN JEMBEC (March 31, 1987)
  • K864256 — TRYPTONE WATER (1%) (March 31, 1987)

Other clearances for product code JSG

  • K882495 — THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (July 1, 1988)
  • K881542 — HEART INFUSION AGAR (April 18, 1988)
  • K881550 — OF BASAL MEDIUM (April 18, 1988)
  • K881563 — TRYPTOSE PHOSPHATE BROTH (April 18, 1988)
  • K881548 — MPH AGAR (April 18, 1988)
  • K881528 — CASEIN PEPTONE, LOW VITAMIN (April 18, 1988)
  • K881531 — BLOOD AGAR BASE, IMPROVED (April 18, 1988)
  • K881523 — DEXTROSE TRYPTONE BROTH (April 18, 1988)
  • K881558 — TRYPTOSE AGAR (April 18, 1988)
  • K881541 — GELATIN (April 18, 1988)

FDA data resources