PERKINELMER 226 SAMPLE COLLECTION DEVICES
FDA 510(k) clearance K121864 · decided 2013-03-12
Clearance details
- K-number
- K121864
- Device name
- PERKINELMER 226 SAMPLE COLLECTION DEVICES
- Applicant
- Perkinelmer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-06-26
- Decision date
- 2013-03-12
- Days to decision
- 259 days
- Clearance type
- Abbreviated
- Product code
- PJC
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Greenville, SC, US
- Third-party review
- No
- Expedited review
- No
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| WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180 (K932661) | Whatman Specialty Products, Inc. | 1996-04-17 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PerkinElmer 226 Sample Collection Device The PerkinElmer 226 Sample Collection Device is i recall (Z-2756-2017) | PerkinElmer Health Sciences, Inc. | 2017-07-24 |
| Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The Perkin recall (Z-0030-2014) | Perkin Elmer Health Sciences, Inc. | 2013-10-18 |