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510(k) K850302

SUPLEX & SUPLEX DILUENT by Pro-Lab, Inc. — Product Code JSK

K850302 is an FDA 510(k) premarket notification submitted by Pro-Lab, Inc. for the device "SUPLEX & SUPLEX DILUENT". The FDA issued a decision of Substantially Equivalent on March 22, 1985. The device falls under product code JSK (Supplement, Culture Media), a Class I device regulated under 21 CFR 866.2450. Pro-Lab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1985
Date Received
January 22, 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 Pro-Lab, Inc.

  • K934383 — PROLEX (STREPTOCCAL GROUPING LATEX KIT) (January 27, 1995)
  • K914419 — AMNIOTEST(TM) (September 1, 1993)
  • K921421 — LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY (July 28, 1992)
  • K903714 — E. COLI 0157 LATEX TEST (January 24, 1991)
  • K894221 — ROSCO PYRR (September 28, 1989)
  • K883996 — X-ACT LDC/IND (October 12, 1988)
  • K883995 — X-ACT UREA/TDA (October 12, 1988)
  • K871121 — PROTECT T.M. (April 14, 1987)
  • K870117 — NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST (March 20, 1987)
  • K861142 — MASTER KIT B (July 10, 1986)

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)
  • K850308 — C.L.A.T. (March 20, 1985)

FDA data resources