Home / 510(k) Clearances / K865102

510(k) K865102

IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS by Sclavo, Inc. — Product Code LES

K865102 is an FDA 510(k) premarket notification submitted by Sclavo, Inc. for the device "IMMPULSE COATED TUBE PHENYTOIN ASSAY REAGENTS". The FDA issued a decision of Substantially Equivalent on January 13, 1987. The device falls under product code LES (Fluorescent Immunoassay, Diphenylhydantoin), a Class II device regulated under 21 CFR 862.3350. Sclavo, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1987
Date Received
December 24, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorescent Immunoassay, Diphenylhydantoin
Device Class
Class II
Regulation Number
862.3350
Review Panel
TX
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)
  • K880199 — CHOLINESTERASE - ACETYTHIOCHOLINE SUBSTRATE (January 27, 1989)
  • K873496 — ATYPICAL CHOLINESTERASE (January 27, 1989)
  • K884035 — SAITRON 430 RANDOM ACCESS CHEMISTRY ANALYZER (December 29, 1988)

Other clearances for product code LES

  • K844990 — SYVA ADVANCE EMIT PHENYTOIN ASSAY (January 23, 1985)
  • K831154 — STRATUS PHENYTOIN FLUOROMETRIC ENZYME (May 16, 1983)
  • K820187 — SYVA ADVANCE SYS. EMIT,(R)-AED(R) PHENY (February 12, 1982)
  • K813538 — PHENYTOIN FLUORESCENT IMMUNOASSAY (December 31, 1981)
  • K811025 — AMES TDA TM PHENYTOIN TEST (April 29, 1981)
  • K801736 — AMES TDA TM PHENYTOIN TEST (August 20, 1980)

FDA data resources