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510(k) K954073

STC DIAGNOSTICS LSD MICRO-PLATE EIA by Solarcare Technologies Corp,Inc. — Product Code DLB

K954073 is an FDA 510(k) premarket notification submitted by Solarcare Technologies Corp,Inc. for the device "STC DIAGNOSTICS LSD MICRO-PLATE EIA". The FDA issued a decision of Substantially Equivalent on November 29, 1995. The device falls under product code DLB (Radioimmunoassay, Lsd (125-I)), a Class II device regulated under 21 CFR 862.3580. Solarcare Technologies Corp,Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1995
Date Received
August 30, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Lsd (125-I)
Device Class
Class II
Regulation Number
862.3580
Review Panel
TX
Submission Type

Other clearances by Solarcare Technologies Corp,Inc.

  • K954326 — STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY (July 23, 1996)
  • K954156 — STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY (July 22, 1996)
  • K955905 — STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY (May 30, 1996)
  • K954158 — STC DIAGNOSTICS AUTO-LYTE PH ASSAY (April 30, 1996)
  • K940048 — STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION (March 19, 1996)
  • K954266 — STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY (October 13, 1995)
  • K935573 — AMPHETAMINES MICRO-PLATE EIA (July 14, 1995)
  • K935565 — OPIATES MICRO-PLATE ASSAY (July 14, 1995)
  • K950308 — STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA (April 14, 1995)
  • K944056 — AUTO-LYTE METHADONE DIA (December 29, 1994)

Other clearances for product code DLB

  • K961436 — ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT) (June 21, 1996)
  • K955448 — EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS (February 23, 1996)
  • K955814 — CEDIA DAU LSD ASSAY (February 9, 1996)
  • K891167 — COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT (May 3, 1989)
  • K874270 — REVISED LABELING FOR LSD TEST KIT (November 13, 1987)
  • K860525 — ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD (April 11, 1986)

FDA data resources