Panels › Hematology › Product code JPD · Class 2
Hemoglobin A2 Quantitation
Regulation 864.7400
0510(k)s in 12 months (13 all time)
0recalls in 12 months (5 all time)
5recalls that name a 510(k)
Top companies in JPD
| Company | 510(k)s | Recalls |
|---|---|---|
| Helena Laboratories | 6 | 0 |
| Bio-Rad | 4 | 0 |
| Bio-Rad Laboratories Inc | 0 | 3 |
| Tosoh Bioscience Inc | 0 | 2 |
| Drew Scientific , Ltd. | 1 | 0 |
| Isolab, Inc. | 1 | 0 |
| Tosoh Medics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 14, 2002 | K020489 | G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE Tosoh Medics, Inc. | JPD |
| Jun 10, 1999 | K991127 | VARIANT II B-THALASSEMIA Bio-Rad | JPD |
| Mar 11, 1993 | K924122 | VARIANT BETA-THALASSEMIA SHORT PROGRAM Bio-Rad | JPD |
| Nov 16, 1992 | K924496 | GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT Drew Scientific , Ltd., GB | JPD |
| Aug 25, 1992 | K923318 | COLUMNMATE BETA-THAL HBA2 CONTROL - NORMAL Helena Laboratories | JPD |
| Aug 25, 1992 | K923317 | COLUMNMATE BETA THAL HBA2 CONTROL-ABNORMAL Helena Laboratories | JPD |
| Dec 17, 1991 | K913384 | COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 Helena Laboratories | JPD |
| Jan 18, 1990 | K896168 | HEMOGLOBIN A2 MICRO COLUMN TEST Bio-Rad | JPD |
| Feb 24, 1988 | K875102 | DETER. OF HEMOGLOBIN A2 USING THE DIAMAT Bio-Rad | JPD |
| Feb 1, 1983 | K823870 | BETA THALQUIK COLUMN #5341 Helena Laboratories | JPD |
| Aug 18, 1981 | K812077 | HELENA SICKLE-THAL QUIK COLUMN METHOD Helena Laboratories | JPD |
| Jan 9, 1981 | K803108 | HELENA HBA2 QUIK COLUMN METHOD Helena Laboratories | JPD |
| Jul 21, 1980 | K801410 | HEMOHLOBIN A2 CONTROL-LYOPHILIZED Isolab, Inc. | JPD |
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