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510(k) K841210

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

K841210 is an FDA 510(k) premarket notification submitted by Smith River Biologicals for the device "SELECTIVE & NON-DIFFERENTIAL". The FDA issued a decision of Substantially Equivalent on April 4, 1984. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2360. 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, Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2360
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)
  • K841203 — GENERAL NUTRIENT BROTH (April 4, 1984)
  • K841212 — SINGLE BIOCHEMICAL TEST (April 4, 1984)
  • K841205 — NON PROPAGATING TRANSPORT (April 4, 1984)

Other clearances for product code JSJ

  • K882463 — POTATO DEXTROSE AGAR (PDA) - PRODUCT #P3421 (June 22, 1988)
  • K881544 — LITTMAN AGAR (April 18, 1988)
  • K881524 — DERMATOPHYTE TEST MEDIUM (April 18, 1988)
  • K881571 — YM BROTH (April 18, 1988)
  • K881573 — PHYTONE YEAST EXTRACT AGAR (April 18, 1988)
  • K881578 — STREPTOSEL (April 18, 1988)
  • K881561 — TERGITOL 7 BROTH (April 18, 1988)
  • K881526 — CHAPMAN STONE MEDIUM (April 18, 1988)
  • K881565 — INHIBITORY MOLD AGAR (April 18, 1988)
  • K881547 — MITIS SALIVARIUS AGAR (April 18, 1988)

FDA data resources