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510(k) K771793

DHEA TEST SET by Wien Laboratories, Inc. — Product Code CIY

K771793 is an FDA 510(k) premarket notification submitted by Wien Laboratories, Inc. for the device "DHEA TEST SET". The FDA issued a decision of Substantially Equivalent on November 2, 1977. The device falls under product code CIY (Radioimmunoassay, Androsterone), a Class I device regulated under 21 CFR 862.1080. Wien Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1977
Date Received
September 22, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Androsterone
Device Class
Class I
Regulation Number
862.1080
Review Panel
CH
Submission Type

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)
  • K821653 — PROTRIPTYLINE TRI-CY TEST SET (June 14, 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)

FDA data resources