The following data is part of a premarket notification filed by Clasrock with the FDA for Filter Sampler Blood Serum Filter.
| Device ID | K771985 |
| 510k Number | K771985 |
| Device Name: | FILTER SAMPLER BLOOD SERUM FILTER |
| Classification | Tubes, Vacuum Sample, With Anticoagulant |
| Applicant | CLASROCK 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GIM |
| CFR Regulation Number | 862.1675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-10-19 |
| Decision Date | 1977-11-02 |