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510(k) K851598

THIOGLYCOLLATE WITHOUT INDICATOR by Preferred Micro-Media — Product Code JSG

K851598 is an FDA 510(k) premarket notification submitted by Preferred Micro-Media for the device "THIOGLYCOLLATE WITHOUT INDICATOR". The FDA issued a decision of Substantially Equivalent on May 10, 1985. The device falls under product code JSG (Culture Media, Non-Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2300. Preferred Micro-Media has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 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 Non-Differential
Device Class
Class I
Regulation Number
866.2300
Review Panel
MI
Submission Type

Other clearances by Preferred Micro-Media

  • K851594 — SF BROTH (May 14, 1985)
  • K851593 — SELECTIVE STREPTOCOCCUS AGAR (May 13, 1985)
  • K851597 — TRIPLE SUGAR IRON AGAR (May 13, 1985)
  • K851596 — SIM MEDIUM (May 13, 1985)
  • K851595 — SIMMONS CITRATE AGAR (May 13, 1985)
  • K851591 — PHENYLETHYL ALCOHOL AGAR W/5%SHEEP BLOOD (May 13, 1985)
  • K851592 — SABOURAUD DEXTROSE AGAR (May 13, 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 JSG

  • K882495 — THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (July 1, 1988)
  • K881542 — HEART INFUSION AGAR (April 18, 1988)
  • K881550 — OF BASAL MEDIUM (April 18, 1988)
  • K881563 — TRYPTOSE PHOSPHATE BROTH (April 18, 1988)
  • K881548 — MPH AGAR (April 18, 1988)
  • K881528 — CASEIN PEPTONE, LOW VITAMIN (April 18, 1988)
  • K881531 — BLOOD AGAR BASE, IMPROVED (April 18, 1988)
  • K881523 — DEXTROSE TRYPTONE BROTH (April 18, 1988)
  • K881558 — TRYPTOSE AGAR (April 18, 1988)
  • K881541 — GELATIN (April 18, 1988)

FDA data resources