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510(k) K781489

ACID PHOSPHATASE DIAG. KIT by Sclavo, Inc. — Product Code CJN

K781489 is an FDA 510(k) premarket notification submitted by Sclavo, Inc. for the device "ACID PHOSPHATASE DIAG. KIT". The FDA issued a decision of Substantially Equivalent on October 3, 1978. The device falls under product code CJN (Acid Phosphatase, Nitrophenylphosphate), a Class II device regulated under 21 CFR 862.1020. Sclavo, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1978
Date Received
August 28, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid Phosphatase, Nitrophenylphosphate
Device Class
Class II
Regulation Number
862.1020
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)

FDA data resources