510(k) K872843
- Device
- OVEIA (TM) DUAL ANALYTE
- Applicant
- BOOTS-CELLTECH DIAGNOSTICS, INC.
- 510(k) number
- K872843
- Product code
- JLP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-02-02
- Date received
- 1987-07-20
- Regulation
- 862.1605
- Classification name
- Spectrophotometric Method, Pregnanediol
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN G SIMPSON
- Address
- 240 Bath Rd. Slough Sl1 4et Berkshire, England GB
FDA Registration Numbers#
- 3012725363
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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