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510(k) K851596

SIM MEDIUM by Preferred Micro-Media — Product Code JSH

K851596 is an FDA 510(k) premarket notification submitted by Preferred Micro-Media for the device "SIM MEDIUM". The FDA issued a decision of Substantially Equivalent on May 13, 1985. The device falls under product code JSH (Culture Media, Non-Selective And Differential), a Class I device regulated under 21 CFR 866.2320. 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, Non-Selective And Differential
Device Class
Class I
Regulation Number
866.2320
Review Panel
MI
Submission Type

Other clearances by Preferred Micro-Media

  • K851594 — SF BROTH (May 14, 1985)
  • K851595 — SIMMONS CITRATE AGAR (May 13, 1985)
  • K851597 — TRIPLE SUGAR IRON AGAR (May 13, 1985)
  • K851593 — SELECTIVE STREPTOCOCCUS AGAR (May 13, 1985)
  • K851592 — SABOURAUD DEXTROSE AGAR (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)
  • K851599 — TRICHOMONAS BROTH (KUPFORBERG (May 8, 1985)
  • K851577 — BILE ESCULIN AZIDE AGAR (May 8, 1985)

Other clearances for product code JSH

  • K881559 — UREA AGAR BASE (April 18, 1988)
  • K881560 — UREA BROTH (April 18, 1988)
  • K881551 — PHENOL RED BROTH BASE (April 18, 1988)
  • K881540 — FLO AGAR (April 18, 1988)
  • K881486 — DNASE TEST AGAR (April 18, 1988)
  • K881553 — RUSSELL DOUBLE SUGAR AGAR (April 18, 1988)
  • K880121 — MOELLERS DECARBOXYLASE, BASE (March 31, 1988)
  • K880117 — OF MEDIUM BASE (March 30, 1988)
  • K873270 — ACTINOMYCETE DIFFERENTIAL MEDIA (November 4, 1987)
  • K873263 — MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA (October 28, 1987)

FDA data resources