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510(k) K834015

SELENITE BROTH by Micro Media Laboratories — Product Code JSD

K834015 is an FDA 510(k) premarket notification submitted by Micro Media Laboratories for the device "SELENITE BROTH". The FDA issued a decision of Substantially Equivalent on December 22, 1983. The device falls under product code JSD (Culture Media, Selective Broth), 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
December 22, 1983
Date Received
November 21, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective Broth
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)
  • K851347 — KANAMYCIN-VANCOMYCIN-LAKED BLOOD AGAR (April 19, 1985)
  • K851345 — PURPLE BROTH (April 19, 1985)
  • K851348 — COBA AGAR (April 19, 1985)
  • K851346 — PHENYLALANINE AGAR (April 19, 1985)
  • K851343 — BROM CRESOL PURPLE STARCH (April 19, 1985)
  • K850845 — 0.85% SALINE (March 20, 1985)
  • K850844 — V AGAR (March 20, 1985)

Other clearances for product code JSD

  • K883075 — FASTIDIOUS INOCULUM BROTH (August 15, 1988)
  • K880107 — CAMPY BROTH (March 30, 1988)
  • K873324 — SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331 (October 2, 1987)
  • K873218 — BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802 (September 23, 1987)
  • K871447 — TODD HEWITT W/CNA (LIM BROTH) (May 13, 1987)
  • K871640 — ALKALINE PEPTONE WATER (May 13, 1987)
  • K870594 — T9802 TSB W/6.5% NACL (March 30, 1987)
  • K853609 — APL TRYPTIC SOY BROTH (September 12, 1985)
  • K844547 — TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE (January 16, 1985)
  • K841836 — SELECTIVE CULTURE MED. TRICHOMONAS (May 14, 1984)

FDA data resources