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510(k) K853609

APL TRYPTIC SOY BROTH by Apl Medical Supplies — Product Code JSD

K853609 is an FDA 510(k) premarket notification submitted by Apl Medical Supplies for the device "APL TRYPTIC SOY BROTH". The FDA issued a decision of Substantially Equivalent on September 12, 1985. The device falls under product code JSD (Culture Media, Selective Broth), a Class I device regulated under 21 CFR 866.2360. Apl Medical Supplies has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1985
Date Received
August 29, 1985
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 Apl Medical Supplies

  • K853610 — APL MOTILITY INDOLE ORNITHINE AGAR (September 16, 1985)
  • K853619 — APL TRIPLE SUGAR IRON AGAR (September 16, 1985)
  • K853618 — APL SIM MEDIUM (September 16, 1985)
  • K853617 — APL SIMMONS CITRATE AGAR (September 16, 1985)
  • K853611 — APL XYLOSE LYSINE DEOXYCHOLATE AGAR (September 12, 1985)
  • K853612 — APL DNASE TEST AGAR (September 6, 1985)
  • K853615 — APL BILE ESCULIN/AZIDE AGAR (September 6, 1985)
  • K853616 — APL CHLAMYDOSPORE AGAR (September 6, 1985)
  • K853613 — APL GN BROTH (September 6, 1985)
  • K853614 — APL FLUID THIOGLYCOLLATE MEDIUM (September 6, 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)
  • K844547 — TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE (January 16, 1985)
  • K841836 — SELECTIVE CULTURE MED. TRICHOMONAS (May 14, 1984)
  • K840971 — SELECTIVE CULTURE MEDIUM (April 13, 1984)

FDA data resources