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510(k) K874748

IMMPULSE DIGOXIN ASSAY REAGENTS by Sclavo, Inc. — Product Code LCS

K874748 is an FDA 510(k) premarket notification submitted by Sclavo, Inc. for the device "IMMPULSE DIGOXIN ASSAY REAGENTS". The FDA issued a decision of Substantially Equivalent on February 19, 1988. The device falls under product code LCS (Radioimmunoassay, Digoxin (125-I)), a Class II device regulated under 21 CFR 862.3320. Sclavo, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 1988
Date Received
November 18, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Digoxin (125-I)
Device Class
Class II
Regulation Number
862.3320
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)
  • 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 LCS

  • K922353 — DIGOXIN COATED TUBE RIA (August 24, 1992)
  • K913562 — QMS - DIGOXIN (August 30, 1991)
  • K895828 — INNOFLUOR DIGOXIN REAGENT SET (October 30, 1989)
  • K884707 — FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT (January 17, 1989)
  • K864802 — DART DIGOXIN ASSAY (February 12, 1987)
  • K820154 — TDX DIGOXIN (February 5, 1982)
  • K812749 — ULTRA-DIG (October 19, 1981)
  • K803047 — I-125 LABELED DIGOXIN (December 22, 1980)
  • K801490 — DIGOXIN EIA KIT (July 14, 1980)
  • K801413 — AMERLEX DIGOXIN RIA KIT (July 8, 1980)

FDA data resources