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510(k) K850733

MULTIPURPOSE CULTURE MEDIUM by Roseville Medical Laboratoriesu — Product Code JSG

K850733 is an FDA 510(k) premarket notification submitted by Roseville Medical Laboratoriesu for the device "MULTIPURPOSE CULTURE MEDIUM". The FDA issued a decision of Substantially Equivalent on March 20, 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. Roseville Medical Laboratoriesu has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1985
Date Received
February 20, 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 Roseville Medical Laboratoriesu

  • K850731 — CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP. TESTING (March 20, 1985)
  • K850734 — DIFFERENTIAL CULTURE MEDIUM (March 20, 1985)
  • K850732 — CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI (March 20, 1985)
  • K850738 — SUPPLEMENT FOR CULTURE MEDIUM (March 20, 1985)
  • K850736 — SELECTIVE CULTURE MEDIUM (March 20, 1985)
  • K850737 — TRANSPORT CULTURE MEDIUM (March 20, 1985)
  • K850735 — ENRICHED CULTURE MEDIUM (March 16, 1985)

Other clearances for product code JSG

  • K882495 — THIOGLYCOLLATE BROTH W/VITA. K & HEMIN - #T3007 (July 1, 1988)
  • K881550 — OF BASAL MEDIUM (April 18, 1988)
  • K881554 — SKIM MILK DEHYDRATED (April 18, 1988)
  • K881548 — MPH AGAR (April 18, 1988)
  • K881563 — TRYPTOSE PHOSPHATE BROTH (April 18, 1988)
  • K881542 — HEART INFUSION AGAR (April 18, 1988)
  • K881531 — BLOOD AGAR BASE, IMPROVED (April 18, 1988)
  • K881528 — CASEIN PEPTONE, LOW VITAMIN (April 18, 1988)
  • K881523 — DEXTROSE TRYPTONE BROTH (April 18, 1988)
  • K881541 — GELATIN (April 18, 1988)

FDA data resources