Diazyme PLAC® Test for Lp-PLA2 Activity
FDA 510(k) clearance K203136 · decided 2021-08-06
Clearance details
- K-number
- K203136
- Device name
- Diazyme PLAC® Test for Lp-PLA2 Activity
- Applicant
- Diazyme Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-10-20
- Decision date
- 2021-08-06
- Days to decision
- 290 days
- Clearance type
- Special
- Product code
- NOE
- Device class
- 2
- Regulation number
- 866.5600
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Poway, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PLAC TEST FOR LP-PLA2 ACTIVITY (K141575) | Diadexus, Inc. | 2014-12-15 |
| PLAC TEST REAGENT KIT, MODELS 90107, 90112, 90115, 90116, 10-0112, 10-0113, 10-0115 (K101853) | Diadexus, Inc. | 2011-01-03 |
| PLAC TEST REAGENT KIT,CALIBRATOR KIT, LP-PLA2 CONTROL KIT, MODEL(S) 90107,90109,90109 (K072599) | Diadexus, Inc. | 2007-12-20 |
| MODIFICATION TO DIADEXUS PLAC TEST (K062234) | Diadexus, Inc. | 2006-09-11 |
| DIADEXUS PLAC TEST (K050523) | Diadexus, Inc. | 2005-06-15 |
| MODIFICATION TO DIADEXUS PLAC TEST (K040101) | Diadexus, Inc. | 2004-02-05 |
| DIADEXUS PLAC TEST (K030477) | Diadexus, Inc. | 2003-07-18 |
Recalls involving this device
No recalls on record reference this clearance.