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510(k) K833789

PHASE II THEOPHYLLINE RADIOIMMUNOASSAY by Medical & Scientific Designs, Inc. — Product Code LCA

K833789 is an FDA 510(k) premarket notification submitted by Medical & Scientific Designs, Inc. for the device "PHASE II THEOPHYLLINE RADIOIMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on January 24, 1984. The device falls under product code LCA (Radioimmunoassay, Theophylline), a Class II device regulated under 21 CFR 862.3880. Medical & Scientific Designs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 1984
Date Received
October 31, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Theophylline
Device Class
Class II
Regulation Number
862.3880
Review Panel
TX
Submission Type

Other clearances by Medical & Scientific Designs, Inc.

  • K862960 — PHASE II FERRITIN RADIOIMMUNOASSAY KIT (August 27, 1986)
  • K853224 — PHASE II B-12/FOLATE KIT (October 3, 1985)
  • K840901 — PHASE II FREE T4 KIT (April 25, 1984)
  • K840328 — PHASE II HCG KIT (April 19, 1984)
  • K834219 — PHASE II CORTISOL KIT (February 4, 1984)
  • K832499 — PHASE II TSH KIT (September 12, 1983)
  • K832210 — GAMMA PHOTON GAMMA COUNTER (August 24, 1983)
  • K832209 — KINETI COUNT 24 GAMMA COUNTER (August 24, 1983)
  • K831064 — PHASE II T3 RADIOIMMUNOASSAY KIT (May 9, 1983)
  • K830900 — UPTAKE T3 RADIOIMMUNOASSAY KIT (April 18, 1983)

Other clearances for product code LCA

  • K880291 — THEOPHYLLINE TEST KIT REF. #A874799 (March 24, 1988)
  • K821862 — QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM. (July 6, 1982)
  • K821347 — BIO-MAG THEOPHYLLINE (125I) RADIOIMMUN. (May 28, 1982)
  • K792062 — THEOPHYLLINE RIASSAY (February 25, 1980)

FDA data resources