510(k) K932661
- Device
- WHATMAN BODY FLUID COLLECTION PAPER:WHATMAN BFC180
- Applicant
- WHATMAN SPECIALTY PRODUCTS, INC.
- 510(k) number
- K932661
- Product code
- PJC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-04-17
- Date received
- 1993-06-02
- Regulation
- 862.1675
- Classification name
- Newborn Screening Specimen Collection Paper
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARD J COPPOLA
- Address
- 6 Just Rd. Fairfield NJ US 07004 07004
FDA Registration Numbers#
- 2020726
- 3007145015
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PJC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K121864 | PERKINELMER 226 SAMPLE COLLECTION DEVICES | Perkinelmer, Inc. | 2013-03-12 |
Legacy Summary#
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FDA Review#
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