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510(k) K810919

HEMOGLOBIN ELECTROPHORESIS CONTROL by Isolab, Inc. — Product Code JBD

K810919 is an FDA 510(k) premarket notification submitted by Isolab, Inc. for the device "HEMOGLOBIN ELECTROPHORESIS CONTROL". The FDA issued a decision of Substantially Equivalent on April 23, 1981. The device falls under product code JBD (System, Analysis, Electrophoretic Hemoglobin), a Class II device regulated under 21 CFR 864.7440. Isolab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1981
Date Received
April 6, 1981
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 Isolab, Inc.

  • K951014 — ISOLAB'S T4 TEST KIT (October 18, 1996)
  • K950481 — NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT (February 1, 1996)
  • K943547 — PHENYLALANINE TEST KIT (January 26, 1996)
  • K950803 — ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE (September 21, 1995)
  • K950415 — FLUOROSCAN NEONATAL (September 5, 1995)
  • K942222 — QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS (January 20, 1995)
  • K942276 — QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY (January 20, 1995)
  • K944185 — ISOSCAN (November 17, 1994)
  • K934013 — RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT (April 26, 1994)
  • K923153 — HEMOCARD, HEMOGLOBIN C ASSAY (January 27, 1994)

Other clearances for product code JBD

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

FDA data resources