Home / 510(k) Clearances / K770765

510(k) K770765

REAGENT SET, RENORPACE by G.D. Searle and Co. — Product Code DPA

K770765 is an FDA 510(k) premarket notification submitted by G.D. Searle and Co. for the device "REAGENT SET, RENORPACE". The FDA issued a decision of Substantially Equivalent on June 24, 1977. The device falls under product code DPA (Apparatus, General Use, Thin Layer Chromatography), a Class I device regulated under 21 CFR 862.2270. G.D. Searle and Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1977
Date Received
April 27, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, General Use, Thin Layer Chromatography
Device Class
Class I
Regulation Number
862.2270
Review Panel
TX
Submission Type

Other clearances by G.D. Searle and Co.

  • K821159 — IN-LINE OXYGEN MONITORING SYSTEM (May 25, 1982)
  • K811068 — BYPASS COIL (May 27, 1981)
  • K811071 — VENOUS OXYGEN PROBE (May 5, 1981)
  • K803238 — INTRAVASCULAR CATHETER (April 23, 1981)
  • K810630 — SILICONE ELASTOMER COATED LATEX FOLEY (March 31, 1981)
  • K810131 — ADMINISTRATION SET (February 26, 1981)
  • K802485 — SEARLE VASCULAR LOOPS (February 12, 1981)
  • K801805 — METRONIDAZOLE DISCS (February 10, 1981)
  • K810112 — SWR DISPOSABLE PREP RAZOR (February 4, 1981)
  • K802213 — WHITE KNIGHT BOVIE CORD/SUCTION TUBE (October 10, 1980)

Other clearances for product code DPA

  • K904326 — DE-TOX TUBES A AND DE-TOX TUBES B (January 17, 1991)
  • K884176 — CHROMATOGRAPHY KIT (April 4, 1989)
  • K791431 — TECHNICON FAST-LC SYS. FOR THEOPHYLLINE (October 11, 1979)
  • K760908 — MINIATURE ASCENDING PAPER CHROMATO- (November 19, 1976)

FDA data resources