510(k) K872568
- Device
- ROTASCREEN
- Applicant
- MERCIA DIAGNOSTICS LTD.
- 510(k) number
- K872568
- Product code
- GOB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-09-14
- Date received
- 1987-06-29
- Regulation
- 866.3020
- Classification name
- Antigens, Ha (including Ha Control), Adenovirus 1-33
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- OLLIVER PH.D.
- Address
- Mercia Houseet Broadford Park Guildford, Surrey England GB GU4 8EW GU4 8EW
FDA Registration Numbers#
- 3016733849
- 3043196750
- 3031915160
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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