WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180
FDA 510(k) clearance K932661 · decided 1996-04-17
Clearance details
- K-number
- K932661
- Device name
- WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180
- Applicant
- Whatman Specialty Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-06-02
- Decision date
- 1996-04-17
- Days to decision
- 1050 days
- Clearance type
- Traditional
- Product code
- PJC
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Fairfield, NJ, US
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| PERKINELMER 226 SAMPLE COLLECTION DEVICES (K121864) | Perkinelmer, Inc. | 2013-03-12 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Whatman Body Fluid Collection Paper- 903 California Newborn Screening Card Ref 110534 903 recall (Z-2384-2010) | Whatman, Inc. | 2010-09-07 |
| Whatman Body Fluid Collection Paper 903, Ref: 10534790, for IVD use. Whatman Inc., Florham recall (Z-1005-2010) | Whatman, Inc. | 2010-03-05 |
| Whatman Body Fluid Collection Paper 903 The device is used by healthcare professionals in recall (Z-1871-2009) | Whatman, Inc. | 2009-09-30 |