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510(k) K851348

COBA AGAR by Micro Media Laboratories — Product Code JSJ

K851348 is an FDA 510(k) premarket notification submitted by Micro Media Laboratories for the device "COBA AGAR". The FDA issued a decision of Substantially Equivalent on April 19, 1985. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2360. Micro Media Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1985
Date Received
April 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2360
Review Panel
MI
Submission Type

Other clearances by Micro Media Laboratories

  • K853691 — TERGITOL 7 AGAR (September 17, 1985)
  • K853690 — COLUMBIZ BLOOD 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)
  • K850845 — 0.85% SALINE (March 20, 1985)
  • K850844 — V AGAR (March 20, 1985)
  • K850846 — SALT BROTH (March 20, 1985)

Other clearances for product code JSJ

  • K882463 — POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (June 22, 1988)
  • K881544 — LITTMAN AGAR (April 18, 1988)
  • K881524 — DERMATOPHYTE TEST MEDIUM (April 18, 1988)
  • K881571 — YM BROTH (April 18, 1988)
  • K881573 — PHYTONE YEAST EXTRACT AGAR (April 18, 1988)
  • K881578 — STREPTOSEL (April 18, 1988)
  • K881561 — TERGITOL 7 BROTH (April 18, 1988)
  • K881526 — CHAPMAN STONE MEDIUM (April 18, 1988)
  • K881565 — INHIBITORY MOLD AGAR (April 18, 1988)
  • K881547 — MITIS SALIVARIUS AGAR (April 18, 1988)

FDA data resources