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510(k) K851343

BROM CRESOL PURPLE STARCH by Micro Media Laboratories — Product Code JSH

K851343 is an FDA 510(k) premarket notification submitted by Micro Media Laboratories for the device "BROM CRESOL PURPLE STARCH". The FDA issued a decision of Substantially Equivalent on April 19, 1985. The device falls under product code JSH (Culture Media, Non-Selective And Differential), a Class I device regulated under 21 CFR 866.2320. 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, Non-Selective And Differential
Device Class
Class I
Regulation Number
866.2320
Review Panel
MI
Submission Type

Other clearances by Micro Media Laboratories

  • K853690 — COLUMBIZ BLOOD AGAR (September 17, 1985)
  • K853691 — TERGITOL 7 AGAR (September 17, 1985)
  • K851344 — OXIDATIVE FORMENTIVE MEDIUM (April 22, 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 JSH

  • K881551 — PHENOL RED BROTH BASE (April 18, 1988)
  • K881486 — DNASE TEST AGAR (April 18, 1988)
  • K881553 — RUSSELL DOUBLE SUGAR AGAR (April 18, 1988)
  • K881559 — UREA AGAR BASE (April 18, 1988)
  • K881540 — FLO AGAR (April 18, 1988)
  • K881560 — UREA BROTH (April 18, 1988)
  • K880121 — MOELLERS DECARBOXYLASE, BASE (March 31, 1988)
  • K880117 — OF MEDIUM BASE (March 30, 1988)
  • K873270 — ACTINOMYCETE DIFFERENTIAL MEDIA (November 4, 1987)
  • K873263 — MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA (October 28, 1987)

FDA data resources