510(k) K913384
- Device
- COLUMNMATE(TM) BETA-THAL CAT. NO. 4515
- Applicant
- HELENA LABORATORIES
- 510(k) number
- K913384
- Product code
- JPD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-12-17
- Date received
- 1991-07-29
- Regulation
- 864.7400
- Classification name
- Hemoglobin A2 Quantitation
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- PAT FRANKS
- Address
- 1530 Lindbergh Dr. P.O. Box 752 Beaumont TX US 77704 77704
FDA Registration Numbers#
- 1000487132
- 8031673
- 3005529799
- 3006421415
- 3006198300
- 3004529019
- 2915274
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JPD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K020489 | G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE | Tosoh Medics, Inc. | 2002-05-14 |
| K991127 | VARIANT II B-THALASSEMIA | Bio-Rad | 1999-06-10 |
| K924122 | VARIANT BETA-THALASSEMIA SHORT PROGRAM | Bio-Rad | 1993-03-11 |
| K924496 | GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT | Drew Scientific , Ltd. | 1992-11-16 |
| K923317 | COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL | Helena Laboratories | 1992-08-25 |
| K923318 | COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL | Helena Laboratories | 1992-08-25 |
| K896168 | HEMOGLOBIN A2 MICRO COLUMN TEST | Bio-Rad | 1990-01-18 |
| K875102 | DETER. OF HEMOGLOBIN A2 USING THE DIAMAT | Bio-Rad | 1988-02-24 |
| K823870 | BETA THALQUIK COLUMN #5341 | Helena Laboratories | 1983-02-01 |
| K812077 | HELENA SICKLE-THAL QUIK COLUMN METHOD | Helena Laboratories | 1981-08-18 |
| K803108 | HELENA HBA2 QUIK COLUMN METHOD | Helena Laboratories | 1981-01-09 |
| K801410 | HEMOHLOBIN A2 CONTROL-LYOPHILIZED | Isolab, Inc. | 1980-07-21 |
Legacy Summary#
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FDA Review#
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