Home / 510(k) Clearances / K980055

510(k) K980055

CARESIDE GLOBULIN by Exigent Diagnostics, Inc. — Product Code JGE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1998
Date Received
January 6, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Turbidimetric Method, Globulin
Device Class
Class I
Regulation Number
862.1330
Review Panel
CH
Submission Type

Other clearances by Exigent Diagnostics, Inc.

  • K982118 — CARESIDE ANALYZER (July 24, 1998)
  • K981899 — CARESIDE HDL-CHOLESTEROL (July 14, 1998)
  • K981183 — CARESIDE GLUCOSE (May 7, 1998)
  • K980043 — CARESIDE CREATININE (March 30, 1998)
  • K980056 — CARESIDE ANALYZER (March 6, 1998)
  • K980057 — CARESIDE BUN (February 5, 1998)
  • K980041 — CARESIDE ALBUMIN (February 4, 1998)
  • K980042 — CARESIDE TOTAL PROTEIN (February 4, 1998)