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510(k) K841206

NON-SELECTIVE & DIFFERENTIAL by Smith River Biologicals — Product Code JSH

K841206 is an FDA 510(k) premarket notification submitted by Smith River Biologicals for the device "NON-SELECTIVE & DIFFERENTIAL". The FDA issued a decision of Substantially Equivalent on April 17, 1984. The device falls under product code JSH (Culture Media, Non-Selective And Differential), a Class I device regulated under 21 CFR 866.2320. Smith River Biologicals has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 17, 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 Differential
Device Class
Class I
Regulation Number
866.2320
Review Panel
MI
Submission Type

Other clearances by Smith River Biologicals

  • K923892 — SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA (June 21, 1993)
  • K841207 — NON-SELECTIVE & NON-DIFFERENTIAL (April 17, 1984)
  • K841204 — MULTIPLE BIOCHEMICAL TEST (April 17, 1984)
  • K841209 — SELECTIVE AND DIFFERENTIAL (April 17, 1984)
  • K841208 — PROPAGATING TRANSPORT (April 5, 1984)
  • K841211 — SELECTIVE BROTH (April 5, 1984)
  • K841213 — ANTIMICROBIAL SUSCEPT-CULTURE MEDIA (April 4, 1984)
  • K841205 — NON PROPAGATING TRANSPORT (April 4, 1984)
  • K841212 — SINGLE BIOCHEMICAL TEST (April 4, 1984)
  • K841203 — GENERAL NUTRIENT BROTH (April 4, 1984)

Other clearances for product code JSH

  • K881551 — PHENOL RED BROTH BASE (April 18, 1988)
  • K881486 — DNASE TEST AGAR (April 18, 1988)
  • K881553 — RUSSELL DOUBLE SUGAR AGAR (April 18, 1988)
  • K881559 — UREA AGAR BASE (April 18, 1988)
  • K881540 — FLO AGAR (April 18, 1988)
  • K881560 — UREA BROTH (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