The following data is part of a premarket notification filed by Sigma Diagnostics, Inc. with the FDA for Glucose-6-phosphate Dehydrogenase Deficiency Screening Test Kit No. 202-a.
| Device ID | K933934 |
| 510k Number | K933934 |
| Device Name: | GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A |
| Classification | Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening |
| Applicant | SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Contact | Leo Bressler |
| Correspondent | Leo Bressler SIGMA DIAGNOSTICS, INC. 545 SOUTH EWING AVE. St. Louis, MO 63103 |
| Product Code | JBF |
| CFR Regulation Number | 864.7360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-11 |
| Decision Date | 1995-06-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516741521 | K933934 | 000 |