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510(k) K853690

COLUMBIZ BLOOD AGAR by Micro Media Laboratories — Product Code JSG

K853690 is an FDA 510(k) premarket notification submitted by Micro Media Laboratories for the device "COLUMBIZ BLOOD AGAR". The FDA issued a decision of Substantially Equivalent on September 17, 1985. The device falls under product code JSG (Culture Media, Non-Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2300. Micro Media Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1985
Date Received
September 4, 1985
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 Micro Media Laboratories

  • K853691 — TERGITOL 7 AGAR (September 17, 1985)
  • K851344 — OXIDATIVE FORMENTIVE MEDIUM (April 22, 1985)
  • K851343 — BROM CRESOL PURPLE STARCH (April 19, 1985)
  • K851346 — PHENYLALANINE AGAR (April 19, 1985)
  • K851345 — PURPLE BROTH (April 19, 1985)
  • K851347 — KANAMYCIN-VANCOMYCIN-LAKED BLOOD AGAR (April 19, 1985)
  • K851348 — COBA AGAR (April 19, 1985)
  • K850845 — 0.85% SALINE (March 20, 1985)
  • K850844 — V AGAR (March 20, 1985)
  • K850847 — THIOGLYCOLATE MEDIUM W/VITAMIN KL & HEMIN (March 20, 1985)

Other clearances for product code JSG

  • K882495 — THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (July 1, 1988)
  • K881550 — OF BASAL MEDIUM (April 18, 1988)
  • K881554 — SKIM MILK DEHYDRATED (April 18, 1988)
  • K881548 — MPH AGAR (April 18, 1988)
  • K881563 — TRYPTOSE PHOSPHATE BROTH (April 18, 1988)
  • K881542 — HEART INFUSION AGAR (April 18, 1988)
  • K881531 — BLOOD AGAR BASE, IMPROVED (April 18, 1988)
  • K881528 — CASEIN PEPTONE, LOW VITAMIN (April 18, 1988)
  • K881523 — DEXTROSE TRYPTONE BROTH (April 18, 1988)
  • K881541 — GELATIN (April 18, 1988)

FDA data resources