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510(k) K910481

EPO-RIA by Ramco Laboratories, Inc. — Product Code GGT

K910481 is an FDA 510(k) premarket notification submitted by Ramco Laboratories, Inc. for the device "EPO-RIA". The FDA issued a decision of Substantially Equivalent on November 29, 1991. The device falls under product code GGT (Assay, Erythropoietin), a Class II device regulated under 21 CFR 864.7250. Ramco Laboratories, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 1991
Date Received
February 6, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Erythropoietin
Device Class
Class II
Regulation Number
864.7250
Review Panel
HE
Submission Type

Other clearances by Ramco Laboratories, Inc.

  • K983107 — VFE (October 22, 1998)
  • K981208 — TFR (October 21, 1998)
  • K872941 — SPECTRO C (September 4, 1987)
  • K864701 — VWF IMMUNOBLOT (March 30, 1987)
  • K861159 — SPECTRO VWF (May 1, 1986)
  • K831470 — PTH MR (June 22, 1983)
  • K823016 — CANDIDA DETECTION SYSTEM (December 28, 1982)
  • K812056 — SPECTRO FEIRITIN (August 12, 1981)

Other clearances for product code GGT

  • K240182 — Access EPO (April 22, 2024)
  • K183088 — ADVIA Centaur Erythropoietin (EPO) assay (August 2, 2019)
  • K052223 — ACCESS EPO ASSAY (October 6, 2006)
  • K992799 — SANGUI BIOTECH, INC. EPO (ERYTHROPOIETIN) ELISA KIT (June 7, 2000)
  • K983203 — IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 (July 12, 1999)
  • K980737 — ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY (March 23, 1999)
  • K952559 — ERYTHROPOIETIN IMMUNOASSAY KIT (May 29, 1996)
  • K954898 — PREDICTA ERYTHROPOIETIN KIT (MODIFICATION) (February 5, 1996)
  • K936016 — QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) (July 19, 1994)
  • K931756 — QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS (April 21, 1994)

FDA data resources