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510(k) K841203

GENERAL NUTRIENT BROTH by Smith River Biologicals — Product Code JSG

K841203 is an FDA 510(k) premarket notification submitted by Smith River Biologicals for the device "GENERAL NUTRIENT BROTH". The FDA issued a decision of Substantially Equivalent on April 4, 1984. The device falls under product code JSG (Culture Media, Non-Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2300. Smith River Biologicals has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1984
Date Received
March 12, 1984
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 Smith River Biologicals

  • K923892 — SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA (June 21, 1993)
  • K841206 — NON-SELECTIVE & DIFFERENTIAL (April 17, 1984)
  • K841207 — NON-SELECTIVE & NON-DIFFERENTIAL (April 17, 1984)
  • K841209 — SELECTIVE AND DIFFERENTIAL (April 17, 1984)
  • K841204 — MULTIPLE BIOCHEMICAL TEST (April 17, 1984)
  • K841211 — SELECTIVE BROTH (April 5, 1984)
  • K841208 — PROPAGATING TRANSPORT (April 5, 1984)
  • K841212 — SINGLE BIOCHEMICAL TEST (April 4, 1984)
  • K841210 — SELECTIVE & NON-DIFFERENTIAL (April 4, 1984)
  • K841205 — NON PROPAGATING TRANSPORT (April 4, 1984)

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