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510(k) K821653

PROTRIPTYLINE TRI-CY TEST SET by Wien Laboratories, Inc. — Product Code LFG

K821653 is an FDA 510(k) premarket notification submitted by Wien Laboratories, Inc. for the device "PROTRIPTYLINE TRI-CY TEST SET". The FDA issued a decision of Substantially Equivalent on June 14, 1982. The device falls under product code LFG (Radioimmunoassay, Tricyclic Antidepressant Drugs), a Class II device regulated under 21 CFR 862.3910. Wien Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1982
Date Received
June 3, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Tricyclic Antidepressant Drugs
Device Class
Class II
Regulation Number
862.3910
Review Panel
TX
Submission Type

Intended to measure any of the tricyclic antidepressant drugs in serum or urine.

Other clearances by Wien Laboratories, Inc.

  • K912850 — SHBG (August 12, 1991)
  • K834246 — PROGESTERONE TEST SET 125I 17-OH (February 4, 1984)
  • K832452 — ANDROSTENEDIONE TEST SET 125I (September 12, 1983)
  • K823200 — 125 I-DEHYDROEPIANDROSTERONE SULFATE (November 29, 1982)
  • K821652 — DOXEPIN TRI-CY TEST SET (June 14, 1982)
  • K802728 — 125I-TESTOSTERONE TEST SET (December 11, 1980)
  • K792041 — DHEA-SULFATE TEST SET (October 30, 1979)
  • K781834 — TEST SET, 125 I-DIGOXIN (January 3, 1979)
  • K781599 — I-ESTRIOL TEST SET (October 17, 1978)
  • K772306 — 125I DIGOXIN TEST SET (December 22, 1977)

Other clearances for product code LFG

  • K151348 — Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptylin (August 18, 2015)
  • K142609 — CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine (December 18, 2014)
  • K112395 — WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TEST (September 9, 2011)
  • K072062 — UCP MULTIPLE DRUG SCREEN TEST CUPS (September 20, 2007)
  • K061457 — UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS (August 21, 2006)
  • K021526 — ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE (July 17, 2002)
  • K011545 — VERDICT -II TCA, VERDICT-II MTD (June 8, 2001)
  • K980249 — ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA (March 13, 1998)
  • K870823 — EMIT NORTRIPTYLINE ASSAY (March 20, 1987)
  • K861155 — EMIT DESIPRAMINE ASSAY (May 2, 1986)

FDA data resources