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 Jun 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 55 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jun 24, 1977
Date Received
Apr 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
510(k) Exempt

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 (Apr 23, 1981)
  • K810630 — SILICONE ELASTOMER COATED LATEX FOLEY (Mar 31, 1981)
  • K810131 — ADMINISTRATION SET (Feb 26, 1981)
  • K802485 — SEARLE VASCULAR LOOPS (Feb 12, 1981)
  • K801805 — METRONIDAZOLE DISCS (Feb 10, 1981)
  • K810112 — SWR DISPOSABLE PREP RAZOR (Feb 4, 1981)
  • K802280 — WHITE KNIGHT DRAPE SEAL (Oct 10, 1980)

Other clearances for product code DPA

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

FDA data resources

Source: FDA 510(k) database entry for K770765. Report a data issue: hello@regdatalab.com.