510(k) K874544
- Device
- SNAP(R) CAMPYLOBACTER CULTURE IDENT DIAGNOSTIC KIT
- Applicant
- MOLECULAR BIOSYSTEMS, INC.
- 510(k) number
- K874544
- Product code
- LGO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-08-12
- Date received
- 1987-11-03
- Regulation
- 864.7675
- Classification name
- Test, Leukocyte Typing
- Medical specialty
- Hematology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PETER J WESTKAEMPER
- Address
- 10030 Barnes Canyon Rd. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3013058950
- 2024375
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LGO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K894947 | PLATELIA TOXO IGG KIT | Kallestad Diag, A Div. of Erbamont, Inc. | 1990-03-23 |
| K791118 | HLA CONTROL SERA | Calbiochem-Behring Corp. | 1979-08-03 |
| K761008 | LYMPHOCYTE TYPING, NEGATIVE CONTROL | Hyland Therapeutic Div., Travenol Laboratories | 1977-04-06 |
| K761009 | LYMPHOCYTE TYPING, POSITIVE CONTROL | Hyland Therapeutic Div., Travenol Laboratories | 1977-04-06 |
Legacy Summary#
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FDA Review#
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