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510(k) K851347

KANAMYCIN-VANCOMYCIN-LAKED BLOOD AGAR by Micro Media Laboratories — Product Code JSJ

K851347 is an FDA 510(k) premarket notification submitted by Micro Media Laboratories for the device "KANAMYCIN-VANCOMYCIN-LAKED BLOOD AGAR". The FDA issued a decision of Substantially Equivalent on Apr 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 51 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 19, 1985
Date Received
Apr 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
510(k) Exempt

Other clearances by Micro Media Laboratories

  • K853690 — COLUMBIZ BLOOD AGAR (Sep 17, 1985)
  • K853691 — TERGITOL 7 AGAR (Sep 17, 1985)
  • K851344 — OXIDATIVE FORMENTIVE MEDIUM (Apr 22, 1985)
  • K851348 — COBA AGAR (Apr 19, 1985)
  • K851345 — PURPLE BROTH (Apr 19, 1985)
  • K851343 — BROM CRESOL PURPLE STARCH (Apr 19, 1985)
  • K851346 — PHENYLALANINE AGAR (Apr 19, 1985)
  • K850843 — MUELLER HINTON CHOCOLATE AGAR (Mar 20, 1985)
  • K850841 — MOD THAYER MARTIN MARTIN LEWIS (Mar 20, 1985)
  • K850847 — THIOGLYCOLATE MEDIUM W/VITAMIN KL & HEMIN (Mar 20, 1985)

Other clearances for product code JSJ

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

FDA data resources

Source: FDA 510(k) database entry for K851347. Report a data issue: hello@regdatalab.com.