Home / 510(k) Clearances / K870351

510(k) K870351

EZ COMPLEMENT REAGENTS, 78N2212 by Diamedix Corp. — Product Code DHL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1987
Date Received
January 29, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protein, Complement, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.4100
Review Panel
IM
Submission Type

Other clearances by Diamedix Corp.

  • K093101 — MAGO 4S (January 21, 2011)
  • K021394 — DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM (July 9, 2002)
  • K013956 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN (January 8, 2002)
  • K013628 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM (December 21, 2001)
  • K012449 — DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM (October 26, 2001)
  • K012450 — DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM (October 26, 2001)
  • K012797 — DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM (September 28, 2001)
  • K012795 — DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM (September 28, 2001)
  • K012053 — DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM (August 20, 2001)
  • K002262 — DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM (November 28, 2000)

Other clearances for product code DHL

  • K811445 — KALLESTAD R QUANTIPLATE ALT. PATHWAY T. (June 24, 1981)
  • K811433 — SCRIPPSERA COMPLEMENT CONTROL SERA (June 16, 1981)
  • K770866 — RABBIT COMPLEMENT (June 3, 1977)