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510(k) K032862

INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM by Interlab S.R.L. — Product Code JBD

K032862 is an FDA 510(k) premarket notification submitted by Interlab S.R.L. for the device "INTERLAB ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on February 3, 2004. The device falls under product code JBD (System, Analysis, Electrophoretic Hemoglobin), a Class II device regulated under 21 CFR 864.7440. Interlab S.R.L. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 3, 2004
Date Received
September 12, 2003
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.

  • K053571 — MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOB (June 30, 2006)
  • K040146 — INTERLAB ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM (May 4, 2004)
  • K033187 — INTERLAB IMMUNOFIXATION TEST(S) (November 19, 2003)

Other clearances for product code JBD

  • K053571 — MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOB (June 30, 2006)
  • 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)

FDA data resources