510(k) K885004
- Device
- BACTIGEN(R) N. MENINGITIDIS
- Applicant
- ARMKEL, LLC.
- 510(k) number
- K885004
- Product code
- GTJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-02-07
- Date received
- 1988-12-01
- Regulation
- 866.3390
- Classification name
- Antisera, All Groups, N. Meningitidis
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANN MACLEARIE
- Address
- Half Acre Rd. P.O. Box 1001 Cranbury NJ US 08512 08512
FDA Registration Numbers#
- 3003750284
- 1119779
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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