Home / 510(k) Clearances / K820533

510(k) K820533

B4182-1 by American Scientific Products — Product Code GIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1982
Date Received
March 2, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrometer
Device Class
Class II
Regulation Number
864.5400
Review Panel
HE
Submission Type

Other clearances by American Scientific Products

  • K864824 — INFECTIOUS TISSUE KIT (December 24, 1986)
  • K844042 — BLOOD DILUTION VIAL (October 23, 1984)
  • K831634 — GLUCOSE REAGENT B6360-11 (July 19, 1983)
  • K831626 — UREA NITROGEN-BUN-REAGENTS B6370-11A (July 7, 1983)
  • K831625 — UREA NITROGEN-BUN-REAGENTS B6360-12 (July 7, 1983)
  • K831628 — CREATININE REAGENTS B6370-13 (July 6, 1983)
  • K831624 — GLUCOSE REAGENT KITS-B6370-10A (July 6, 1983)
  • K831627 — CREATININE REAGENTS B6360-10 (July 6, 1983)
  • K831569 — REAGENT CUPS (June 30, 1983)
  • K831571 — ROTOR (June 30, 1983)

Other clearances for product code GIE

  • K820532 — DISPO FIBRIN PIPET TIPS B4182-2 (April 8, 1982)