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510(k) K801410

HEMOHLOBIN A2 CONTROL-LYOPHILIZED by Isolab, Inc. — Product Code JPD

K801410 is an FDA 510(k) premarket notification submitted by Isolab, Inc. for the device "HEMOHLOBIN A2 CONTROL-LYOPHILIZED". The FDA issued a decision of Substantially Equivalent on July 21, 1980. The device falls under product code JPD (Hemoglobin A2 Quantitation), a Class II device regulated under 21 CFR 864.7400. Isolab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1980
Date Received
June 16, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemoglobin A2 Quantitation
Device Class
Class II
Regulation Number
864.7400
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)
  • K942276 — QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY (January 20, 1995)
  • K942222 — QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS (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 JPD

  • K020489 — G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE (May 14, 2002)
  • K991127 — VARIANT II B-THALASSEMIA (June 10, 1999)
  • K924122 — VARIANT BETA-THALASSEMIA SHORT PROGRAM (March 11, 1993)
  • K924496 — GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT (November 16, 1992)
  • K923317 — COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL (August 25, 1992)
  • K923318 — COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL (August 25, 1992)
  • K913384 — COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 (December 17, 1991)
  • K896168 — HEMOGLOBIN A2 MICRO COLUMN TEST (January 18, 1990)
  • K875102 — DETER. OF HEMOGLOBIN A2 USING THE DIAMAT (February 24, 1988)
  • K823870 — BETA THALQUIK COLUMN #5341 (February 1, 1983)

FDA data resources