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510(k) K850738

SUPPLEMENT FOR CULTURE MEDIUM by Roseville Medical Laboratoriesu — Product Code JSK

K850738 is an FDA 510(k) premarket notification submitted by Roseville Medical Laboratoriesu for the device "SUPPLEMENT FOR CULTURE MEDIUM". The FDA issued a decision of Substantially Equivalent on March 20, 1985. The device falls under product code JSK (Supplement, Culture Media), a Class I device regulated under 21 CFR 866.2450. 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
Supplement, Culture Media
Device Class
Class I
Regulation Number
866.2450
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)
  • K850733 — MULTIPURPOSE CULTURE MEDIUM (March 20, 1985)
  • K850732 — CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI (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 JSK

  • K881949 — ATS NAC-PAC SET (May 25, 1988)
  • K881879 — ATS M/15 PHOSPHATE BUFFER, PRODUCT #034-42 (May 13, 1988)
  • K881566 — HEMOGLOBIN POWDER (April 18, 1988)
  • K861997 — PENICILLIN-STREPTOMYCIN-FUNGIZONE MIXTURE (June 10, 1986)
  • K861823 — GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) (May 20, 1986)
  • K861824 — GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) (May 20, 1986)
  • K861791 — PENICILLIN-STREPTOMYCIN-FUNGIZONE (May 20, 1986)
  • K855172 — KWI (TM) G-CO/TWO (February 20, 1986)
  • K853546 — ABBOTT CATION SUPPLEMENT SOLUTION (September 6, 1985)
  • K850302 — SUPLEX & SUPLEX DILUENT (March 22, 1985)

FDA data resources