The following data is part of a premarket notification filed by Immucor, Inc. with the FDA for Potentiating Media For In Vitro Diagnostic Use.
| Device ID | BK830004 |
| 510k Number | BK830004 |
| Device Name: | Potentiating Media For In Vitro Diagnostic Use |
| Classification | Media, Potentiating For In Vitro Diagnostic Use |
| Applicant | Immucor, Inc. 3130 Gateway Drive p.o. Box 5625 Norcross, GA 30091 |
| Product Code | KSG |
| CFR Regulation Number | 864.9600 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-15 |
| Decision Date | 1983-03-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234000235 | BK830004 | 0 |