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510(k) K840216

SODIUM/POTASSIUM REAGENT SYS by Sclavo, Inc. — Product Code JGT

K840216 is an FDA 510(k) premarket notification submitted by Sclavo, Inc. for the device "SODIUM/POTASSIUM REAGENT SYS". The FDA issued a decision of Substantially Equivalent on March 19, 1984. The device falls under product code JGT (Flame Photometry, Sodium), a Class II device regulated under 21 CFR 862.1665. Sclavo, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 1984
Date Received
January 19, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Flame Photometry, Sodium
Device Class
Class II
Regulation Number
862.1665
Review Panel
CH
Submission Type

Other clearances by Sclavo, Inc.

  • K914789 — ELISA CMV IGM (March 4, 1992)
  • K914852 — ELISA TOXO IGM (January 23, 1992)
  • K914420 — ELISA RUBELLA IGM (December 27, 1991)
  • K895943 — NORMAL AND ABNORMAL CONTROL SERA (December 27, 1989)
  • K895822 — TOTAL BILIRUBIN L.F. (November 14, 1989)
  • K895847 — CREATININE 340 (ENZYMATIC) (October 30, 1989)
  • K880049 — CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE (January 27, 1989)
  • K873496 — ATYPICAL CHOLINESTERASE (January 27, 1989)
  • K880199 — CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE (January 27, 1989)
  • K884035 — SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER (December 29, 1988)

Other clearances for product code JGT

  • K896829 — TECHNICON RA SYSTEMS SODIUM (COLORIMETRIC METHOD) (February 23, 1990)
  • K891574 — LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030 (June 9, 1989)
  • K841610 — COMPONENTS FOR POTASSIUM, SODIUM CHLO (May 25, 1984)
  • K834248 — PARALLEL FLAME PHOTOMETER & SODIUM (January 30, 1984)
  • K811886 — CESIUM DILUENT 7.5M (July 23, 1981)
  • K801892 — KLINAR REAGENT PAK, #36010 (October 23, 1980)
  • K770774 — LYTETEK SYSTEM (July 11, 1977)

FDA data resources