510(k) K032161
- Device
- PHEM-ALERT
- Applicant
- FEMTEK,LLC.
- 510(k) number
- K032161
- Product code
- LNW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-09-30
- Date received
- 2003-07-15
- Regulation
- 862.1550
- Classification name
- Paper, Obstetric Ph
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOEL S FADEN
- Address
- 11605 Hitching Post Ln. Rockville MD US 20852 20852
FDA Registration Numbers#
- 3038206980
- 3001519554
- 3012706495
- 3043127647
- 3009238284
- 3018126397
- 3027519599
- 3012725363
- 3008987086
- 3010852191
- 3011630465
- 1221895
- 3043127699
- 3009585529
- 3013077867
- 3021186226
- 3008517993
- 3012073813
- 3016609999
- 3024676893
- 3016621374
- 3024171133
- 3006389770
- 3014883395
- 3014255036
- 3015729142
- 3025041446
- 3005630901
- 3021595883
- 2183650
- 3032109
- 3020956494
- 3012187283
Source Documents#
Other 510(k) Records For Product Code LNW #
Legacy Summary#
summary
FDA Review#
Decision Summary