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510(k) K053571

MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM by Interlab S.R.L. — Product Code JBD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 2006
Date Received
December 22, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Analysis, Electrophoretic Hemoglobin
Device Class
Class II
Regulation Number
864.7440
Review Panel
HE
Submission Type

Other clearances by Interlab S.R.L.

  • K040146 — INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM (May 4, 2004)
  • K032862 — INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM (February 3, 2004)
  • K033187 — INTERLAB IMMUNOFIXATION TEST(S) (November 19, 2003)

Other clearances for product code JBD

  • K032862 — INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM (February 3, 2004)
  • K992199 — ACID HEMOGLOBIN KIT (September 21, 1999)
  • K991362 — HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), A (June 21, 1999)
  • K982426 — SPIFE ALKALINE HEMOGLOBIN (December 17, 1998)
  • K931503 — REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) (August 16, 1993)
  • K931465 — REP ALKALINE HB-15 #3196,-8 #3197,-4 3198 (July 6, 1993)
  • K901143 — REP HEMOGLOBIN IEF KITS (CAT. NO. 3250) (May 23, 1990)
  • K830804 — LABILE REMOVING HEMOLYZING REAGENT (May 4, 1983)
  • K820518 — GELMAN GLYCO-PHORE BUFFER (April 9, 1982)
  • K813395 — CELLULOSE ACETATE-CITRATE AGAR HEMOGLO (December 31, 1981)