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510(k) K990641

CALTAG FETAL HEMOGLOBIN TEST by Caltag Laboratories, Inc. — Product Code GHQ

K990641 is an FDA 510(k) premarket notification submitted by Caltag Laboratories, Inc. for the device "CALTAG FETAL HEMOGLOBIN TEST". The FDA issued a decision of Substantially Equivalent on September 17, 1999. The device falls under product code GHQ (Stain, Fetal Hemoglobin), a Class II device regulated under 21 CFR 864.7455. Caltag Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 17, 1999
Date Received
February 26, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stain, Fetal Hemoglobin
Device Class
Class II
Regulation Number
864.7455
Review Panel
HE
Submission Type

Other clearances by Caltag Laboratories, Inc.

  • K965232 — CALTAG CAL-LYSE (May 14, 1997)
  • K964856 — CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION (January 17, 1997)
  • K963954 — CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY (November 25, 1996)
  • K950916 — CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION (December 21, 1995)
  • K950918 — CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION (December 21, 1995)
  • K950917 — CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION (December 21, 1995)
  • K951073 — CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION (December 21, 1995)
  • K950919 — CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION (December 20, 1995)
  • K944128 — CALTAG CD4 R-PE MONOCLONAL ANTIBODY (June 20, 1995)
  • K944126 — CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES (June 20, 1995)

Other clearances for product code GHQ

  • K892241 — FETAL HEMOGLOBIN (May 17, 1989)

FDA data resources