SPQ CRP Control Level II
FDA 510(k) K935075 · Incstar Corp.
510(k) numberK935075
Submission
- Device name
- SPQ CRP Control Level II
- Applicant
- Incstar Corp.
Stillwater, MN, US - Received
- October 25, 1993
- Decision date
- January 11, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DCN – System, Test, C-Reactive Protein
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
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| K953567 | Incstar 25-HYDROXYVITMIN D 1251 RiaMRG · Traditional | 09/25/1996SE |
| K955363 | Incstar HSZ I/Ii Igg Elisa AssayIGC · Traditional | 07/24/1996SE |
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Questions and answers
When was SPQ CRP Control Level II cleared by the FDA?
SPQ CRP Control Level II (K935075) received a 510(k) decision of Substantially Equivalent on January 11, 1994, 78 days after the submission was received.
What is the product code of K935075?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.