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510(k) K853227

APL PHENYLETHYL ALCOHOL AGAR(WITH 5% SHEEP BLOOD) by Apl Medical Supplies — Product Code JSJ

K853227 is an FDA 510(k) premarket notification submitted by Apl Medical Supplies for the device "APL PHENYLETHYL ALCOHOL AGAR(WITH 5% SHEEP BLOOD)". The FDA issued a decision of Substantially Equivalent on August 19, 1985. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), 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
August 19, 1985
Date Received
August 1, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2360
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)
  • K853610 — APL MOTILITY INDOLE ORNITHINE AGAR (September 16, 1985)
  • K853619 — APL TRIPLE SUGAR IRON AGAR (September 16, 1985)
  • K853609 — APL TRYPTIC SOY BROTH (September 12, 1985)
  • K853611 — APL XYLOSE LYSINE DEOXYCHOLATE AGAR (September 12, 1985)
  • K853613 — APL GN BROTH (September 6, 1985)
  • K853616 — APL CHLAMYDOSPORE AGAR (September 6, 1985)
  • K853612 — APL DNASE TEST AGAR (September 6, 1985)
  • K853615 — APL BILE ESCULIN/AZIDE AGAR (September 6, 1985)

Other clearances for product code JSJ

  • K882463 — POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (June 22, 1988)
  • K881544 — LITTMAN AGAR (April 18, 1988)
  • K881524 — DERMATOPHYTE TEST MEDIUM (April 18, 1988)
  • K881571 — YM BROTH (April 18, 1988)
  • K881573 — PHYTONE YEAST EXTRACT AGAR (April 18, 1988)
  • K881578 — STREPTOSEL (April 18, 1988)
  • K881561 — TERGITOL 7 BROTH (April 18, 1988)
  • K881526 — CHAPMAN STONE MEDIUM (April 18, 1988)
  • K881565 — INHIBITORY MOLD AGAR (April 18, 1988)
  • K881547 — MITIS SALIVARIUS AGAR (April 18, 1988)

FDA data resources