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510(k) K834013

SF BROTH by Micro Media Laboratories — Product Code JSD

K834013 is an FDA 510(k) premarket notification submitted by Micro Media Laboratories for the device "SF BROTH". The FDA issued a decision of Substantially Equivalent on Dec 27, 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 51 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Dec 27, 1983
Date Received
Nov 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
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)
  • K851345 — PURPLE BROTH (Apr 19, 1985)
  • K851346 — PHENYLALANINE AGAR (Apr 19, 1985)
  • K851348 — COBA AGAR (Apr 19, 1985)
  • K851347 — KANAMYCIN-VANCOMYCIN-LAKED BLOOD AGAR (Apr 19, 1985)
  • K851343 — BROM CRESOL PURPLE STARCH (Apr 19, 1985)
  • K850841 — MOD THAYER MARTIN MARTIN LEWIS (Mar 20, 1985)
  • K850843 — MUELLER HINTON CHOCOLATE AGAR (Mar 20, 1985)

Other clearances for product code JSD

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

FDA data resources

Source: FDA 510(k) database entry for K834013. Report a data issue: hello@regdatalab.com.