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510(k) K851593

SELECTIVE STREPTOCOCCUS AGAR by Preferred Micro-Media — Product Code JSJ

K851593 is an FDA 510(k) premarket notification submitted by Preferred Micro-Media for the device "SELECTIVE STREPTOCOCCUS AGAR". The FDA issued a decision of Substantially Equivalent on May 13, 1985. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2360. Preferred Micro-Media has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1985
Date Received
April 16, 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 Preferred Micro-Media

  • K851594 — SF BROTH (May 14, 1985)
  • K851595 — SIMMONS CITRATE AGAR (May 13, 1985)
  • K851592 — SABOURAUD DEXTROSE AGAR (May 13, 1985)
  • K851597 — TRIPLE SUGAR IRON AGAR (May 13, 1985)
  • K851596 — SIM MEDIUM (May 13, 1985)
  • K851591 — PHENYLETHYL ALCOHOL AGAR W/5%SHEEP BLOOD (May 13, 1985)
  • K851598 — THIOGLYCOLLATE WITHOUT INDICATOR (May 10, 1985)
  • K851576 — BIGGY AGAR NICKERSONS MEDIUM (May 9, 1985)
  • K851577 — BILE ESCULIN AZIDE AGAR (May 8, 1985)
  • K851603 — XYLOSE LYSINE DESOXYCHOLATE AGAR (May 8, 1985)

Other clearances for product code JSJ

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

FDA data resources