Quik-Dot C Reactive Protein
FDA 510(k) K892119 · Ampcor, Inc.
510(k) numberK892119
Submission
- Device name
- Quik-Dot C Reactive Protein
- Applicant
- Ampcor, Inc.
Bridgeport, NJ, US - Received
- March 31, 1989
- Decision date
- April 14, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DCK – C-Reactive Protein, Antigen, Antiserum, And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
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| K192118 | CRP VarioDCK · Special | SENTINEL CH. SpA | 11/08/2019SE |
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| K160712 | VITROS Chemistry Products hsCRP ReagentDCK · Traditional | Ortho Clinical Diagnostics | 07/14/2017SE |
| K142993 | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and…DCK · Traditional | Orion Diagnostica, OY | 03/10/2016SE |
| K152433 | VITROS Chemistry Products CRP Slides; VITRO Chemistry Products Calibrator Kit 7DCK · Special | Ortho Clinical Diagnostics | 09/24/2015SE |
| K141689 | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive…DCK · Traditional | Qualigen, Inc. | 01/07/2015SE |
| K121558 | Diazyme Hscrp Poc Test KitDCK · Traditional | Diazyme Laboratories | 09/21/2012SE |
More from Diazyme Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K922297 | Infectious Mononucleosis Qik-Dot Im Dry Card TestKTN · Traditional | 07/14/1992SE |
| K922296 | Imfectious Mononucleosis Im Liquid Card TestKTN · Traditional | 07/14/1992SE |
| K910438 | Dipstick SalmonellaGRM · Traditional | 09/13/1991SE |
| K893873 | Single and Dual Band Dipstick HCG TestDHA · Traditional | 08/21/1989SE |
| K890048 | Quik-Dot ToxoplasmosisLLA · Traditional | 06/09/1989SE |
| K892146 | C Reactive Protein LiquidDCK · Traditional | 04/14/1989SE |
| K890025 | Quik-Dot Antistreptolysin-OGTQ · Traditional | 01/31/1989SE |
| K884750 | Group a Strep, Beta-StrepGTZ · Traditional | 12/22/1988SE |
| K880163 | Pregnancy (HCG) Card & Liquid TestJHJ · Traditional | 05/17/1988SE |
| K880478 | Pregnancy Beta-Hcg Card & Liquid TestJHJ · Traditional | 04/28/1988SE |
Questions and answers
When was Quik-Dot C Reactive Protein cleared by the FDA?
Quik-Dot C Reactive Protein (K892119) received a 510(k) decision of Substantially Equivalent on April 14, 1989, 14 days after the submission was received.
What is the product code of K892119?
The FDA product code is DCK – C-Reactive Protein, Antigen, Antiserum, And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5270.