Home / 510(k) Clearances / K802120

510(k) K802120

HEPA-SHURE -L by Nuclear Medical Laboratories, Inc. — Product Code JJK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1980
Date Received
September 4, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oncometer, Plasma, For Clinical Use
Device Class
Class I
Regulation Number
862.2720
Review Panel
CH
Submission Type

Other clearances by Nuclear Medical Laboratories, Inc.

  • K852438 — NML TSH IRMA (July 12, 1985)
  • K844583 — TSH-STAT (March 5, 1985)
  • K840466 — NML CORTISOL RIA (March 30, 1984)
  • K840589 — TRI-TUBE RIA (March 9, 1984)
  • K832892 — MODIFIED CHORIO-SHURE (October 28, 1983)
  • K832002 — NML-5010/5020 MULTI-DETECTOR SYSTEM (August 8, 1983)
  • K823679 — NML 6000 CT (January 7, 1983)
  • K823053 — NML-TETRA-TUBE RIA (November 10, 1982)
  • K822298 — DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI (September 2, 1982)
  • K820523 — CHORIO-QUANT (March 15, 1982)

Other clearances for product code JJK

  • K863099 — ABBOTT TESTPACK (TM) ACUTE HEP A CONTROL KIT (September 16, 1986)
  • K823196 — SPECIAL CONTROL SERUM FOR HDL-CHOLES (November 29, 1982)
  • K760975 — WEIL ONCOMETER (IL 186) (January 12, 1977)