510(k) K860695
- Device
- GIBCO MYCOTECT KIT (CATALOG NO. 189-5672)
- Applicant
- GIBCO LABORATORIES LIFE TECHNOLOGIES, INC.
- 510(k) number
- K860695
- Product code
- KIW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-03-12
- Date received
- 1986-02-25
- Regulation
- 864.2360
- Classification name
- Kit, Mycoplasma Detection
- Medical specialty
- Hematology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- GARY J SFEIR
- Address
- P.O. Box 68 Grandisland NY US 14072 14072
FDA Registration Numbers#
- 3016741564
- 3010194621
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KIW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K851275 | GIBCO MYCOTECT 189-5670 | Gibco Laboratories Life Technologies, Inc. | 1985-06-21 |
Legacy Summary#
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FDA Review#
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