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510(k) K853236

APL TSA WITH 5% SHEEP BLOOD by Apl Medical Supplies — Product Code KZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1985
Date Received
August 1, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Enriched
Device Class
Class I
Regulation Number
866.2330
Review Panel
MI
Submission Type

Other clearances by Apl Medical Supplies

  • K853618 — APL SIM MEDIUM (September 16, 1985)
  • K853617 — APL SIMMONS CITRATE AGAR (September 16, 1985)
  • K853619 — APL TRIPLE SUGAR IRON AGAR (September 16, 1985)
  • K853610 — APL MOTILITY INDOLE ORNITHINE AGAR (September 16, 1985)
  • K853611 — APL XYLOSE LYSINE DEOXYCHOLATE AGAR (September 12, 1985)
  • K853609 — APL TRYPTIC SOY BROTH (September 12, 1985)
  • K853612 — APL DNASE TEST AGAR (September 6, 1985)
  • K853615 — APL BILE ESCULIN/AZIDE AGAR (September 6, 1985)
  • K853613 — APL GN BROTH (September 6, 1985)
  • K853616 — APL CHLAMYDOSPORE AGAR (September 6, 1985)

Other clearances for product code KZI

  • K884208 — LISTERIA SELECTIVE MEDIUM (OXFORD FORMULATION) (October 25, 1988)
  • K881995 — DIAMOND'S MEDIUM MODIFIED (June 2, 1988)
  • K880134 — MIDDLEBROOK 7H11 AGAR (March 31, 1988)
  • K880131 — LOWENSTEIN-JENSEN, GRUFT (March 31, 1988)
  • K880122 — MIDDLEBROOK 7H9 BROTH (March 31, 1988)
  • K880138 — WALLENSTEIN MEDIUM SLANT (March 30, 1988)
  • K880109 — CYSTINE TRYPTIC MEDIUM BASE (March 30, 1988)
  • K880127 — POTATO DEXTROSE AGAR (March 7, 1988)
  • K874179 — BIOTIS (TM) SABHI (DOUBLE POUR) (January 28, 1988)
  • K874177 — BIOTIS (TM) BCYE (December 4, 1987)