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510(k) K833710

BTC URINE LH ASSAY by Btc Diagnostics, Inc. — Product Code CED

K833710 is an FDA 510(k) premarket notification submitted by Btc Diagnostics, Inc. for the device "BTC URINE LH ASSAY". The FDA issued a decision of Substantially Equivalent on January 30, 1984. The device falls under product code CED (5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase), a Class I device regulated under 21 CFR 862.1520. Btc Diagnostics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1984
Date Received
October 20, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase
Device Class
Class I
Regulation Number
862.1520
Review Panel
CH
Submission Type

Other clearances by Btc Diagnostics, Inc.

  • K841545 — ENZYME IMMUNOASSAY FOR DETECTION HORM (November 27, 1984)
  • K832905 — QUALITATIVE ENZYME IMMUNOASSAY-DETECT (February 3, 1984)
  • K831604 — HCG ACCU-STICK (July 19, 1983)
  • K831125 — BTC URINE LCG ASSAY (May 5, 1983)

Other clearances for product code CED

  • K894288 — PHOSPHORUS TEST ITEM NUMBER 65416 (August 31, 1989)
  • K840151 — EKTACHEM CLINICAL CHEM. SLIDES (March 22, 1984)
  • K820832 — PHOSPHORUS IL (April 15, 1982)
  • K812670 — SANDARE FAST 340 PHOSPHORUS PROCEDURE (October 2, 1981)
  • K811864 — SIGMA PROCEDURE 265-UV (July 31, 1981)
  • K811222 — INORGANIC PHOSPHORUS REAGENTS (May 21, 1981)
  • K802420 — CENTRIFICHEM INORGANIC PHOSPHORUS (October 31, 1980)
  • K790662 — CENTRIFICHEM INORGANIC PHOSPHORUS (May 15, 1979)

FDA data resources