FDA Product Code
FDA Product Code JPD — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7400
510(k) Clearances — 13 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K020489 | G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE | Tosoh Medics, Inc. | 2002-05-14 | Traditional | PDF ↗ |
| K991127 | VARIANT II B-THALASSEMIA | Bio-Rad | 1999-06-10 | Special | PDF ↗ |
| K924122 | VARIANT BETA-THALASSEMIA SHORT PROGRAM | Bio-Rad | 1993-03-11 | Traditional | PDF ↗ |
| K924496 | GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT | Drew Scientific , Ltd. | 1992-11-16 | Traditional | PDF ↗ |
| K923317 | COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL | Helena Laboratories | 1992-08-25 | Traditional | PDF ↗ |
| K923318 | COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL | Helena Laboratories | 1992-08-25 | Traditional | PDF ↗ |
| K913384 | COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 | Helena Laboratories | 1991-12-17 | Traditional | PDF ↗ |
| K896168 | HEMOGLOBIN A2 MICRO COLUMN TEST | Bio-Rad | 1990-01-18 | Traditional | PDF ↗ |
| K875102 | DETER. OF HEMOGLOBIN A2 USING THE DIAMAT | Bio-Rad | 1988-02-24 | Traditional | PDF ↗ |
| K823870 | BETA THALQUIK COLUMN #5341 | Helena Laboratories | 1983-02-01 | Traditional | PDF ↗ |
| K812077 | HELENA SICKLE-THAL QUIK COLUMN METHOD | Helena Laboratories | 1981-08-18 | Traditional | PDF ↗ |
| K803108 | HELENA HBA2 QUIK COLUMN METHOD | Helena Laboratories | 1981-01-09 | Traditional | PDF ↗ |
| K801410 | HEMOHLOBIN A2 CONTROL-LYOPHILIZED | Isolab, Inc. | 1980-07-21 | Traditional | PDF ↗ |
Product code JPD · Class II · Hematology. Data: openFDA.