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510(k) K841212

SINGLE BIOCHEMICAL TEST by Smith River Biologicals — Product Code JSF

K841212 is an FDA 510(k) premarket notification submitted by Smith River Biologicals for the device "SINGLE BIOCHEMICAL TEST". The FDA issued a decision of Substantially Equivalent on Apr 4, 1984. The device falls under product code JSF (Culture Media, Single Biochemical Test), a Class I device regulated under 21 CFR 866.2320. Smith River Biologicals has 11 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 4, 1984
Date Received
Mar 12, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device classification

Device Name
Culture Media, Single Biochemical Test
Device Class
Class I
Regulation Number
866.2320
Review Panel
MI
Submission Type
510(k) Exempt

Other clearances by Smith River Biologicals

  • K923892 — SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA (Jun 21, 1993)
  • K841204 — MULTIPLE BIOCHEMICAL TEST (Apr 17, 1984)
  • K841207 — NON-SELECTIVE & NON-DIFFERENTIAL (Apr 17, 1984)
  • K841206 — NON-SELECTIVE & DIFFERENTIAL (Apr 17, 1984)
  • K841209 — SELECTIVE AND DIFFERENTIAL (Apr 17, 1984)
  • K841208 — PROPAGATING TRANSPORT (Apr 5, 1984)
  • K841211 — SELECTIVE BROTH (Apr 5, 1984)
  • K841213 — ANTIMICROBIAL SUSCEPT-CULTURE MEDIA (Apr 4, 1984)
  • K841203 — GENERAL NUTRIENT BROTH (Apr 4, 1984)
  • K841205 — NON PROPAGATING TRANSPORT (Apr 4, 1984)

Other clearances for product code JSF

  • K880946 — NUTRIENT GELATIN - PRODUCT NUMBER T2860 (Apr 1, 1988)
  • K880120 — MOELLERS DECARBOXYLASE, LYSINE (Mar 31, 1988)
  • K880126 — LAURYL TRYPTOSE BROTH (Mar 31, 1988)
  • K880119 — MOELLERS DECARBOXYLASE, ONITHINE (Mar 31, 1988)
  • K880135 — NITRATE BROTH (Mar 30, 1988)
  • K880106 — ACETAMIDE AGAR SLANT (Mar 30, 1988)
  • K880112 — CYSTINE TRYPTIC MEDIUM W/ MALTOSE (Mar 30, 1988)
  • K880129 — BRILLIANT GREEN BILE BROTH (Mar 30, 1988)
  • K880139 — ONPG TEST REAGENT (Mar 30, 1988)
  • K880113 — CYSTINE TRYPTIC MEDIUM W/LACTOSE (Mar 30, 1988)

FDA data resources

Source: FDA 510(k) database entry for K841212. Report a data issue: hello@regdatalab.com.