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510(k) K810976

ALPHA-THAL SCREEN TM CONTROL by Isolab, Inc. — Product Code LGL

K810976 is an FDA 510(k) premarket notification submitted by Isolab, Inc. for the device "ALPHA-THAL SCREEN TM CONTROL". The FDA issued a decision of Substantially Equivalent on May 29, 1981. The device falls under product code LGL (Assay, Bart'S, Hemoglobin), a Class II device regulated under 21 CFR 864.7500. Isolab, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1981
Date Received
April 10, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Bart'S, Hemoglobin
Device Class
Class II
Regulation Number
864.7500
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 LGL

  • K801771 — ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT (January 16, 1981)

FDA data resources