The following data is part of a premarket notification filed by Helmer Labs., Inc. with the FDA for Environmental Chambers For The Storage Of Platelet.
| Device ID | BK850015 |
| 510k Number | BK850015 |
| Device Name: | Environmental Chambers For The Storage Of Platelet |
| Classification | Chamber, Environmental For The Storage Of Platelet Concentrate |
| Applicant | Helmer Labs., Inc. 5415 Distribution Drive Fort Wayne, IN 46825 |
| Product Code | KSH |
| CFR Regulation Number | 864.9575 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-12 |
| Decision Date | 1985-09-20 |