The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Code Qas 103 Anti-dna Controls.
| Device ID | K791354 |
| 510k Number | K791354 |
| Device Name: | CODE QAS 103 ANTI-DNA CONTROLS |
| Classification | Anti-dna Indirect Immunofluorescent Solid Phase |
| Applicant | AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KTL |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-07-18 |
| Decision Date | 1979-09-17 |