510(k) K770650
- Device
- PRE-DUCED CULTURE MEDIA
- Applicant
- Gibco Laboratories Life Technologies, Inc.
- 510(k) number
- K770650
- Product code
- JSL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-04-15
- Date received
- 1977-04-06
- Regulation
- 866.2390
- Classification name
- Culture Media, Anaerobic Transport
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 9681465
- 2022807
- 1924669
- 2916932
- 8020315
- 9610649
- 9611665
- 3002444944
- 3010407203
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JSL#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K972448 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITHOUT CHARCOAL | Copan Italia Spa | 1997-08-20 |
| K972449 | COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL | Copan Italia Spa | 1997-08-20 |
| K944847 | KULTSURE/STARSWAB ANAEROBIC TRANSPORT SYSTEM | Starplex Scientific, Inc. | 1995-02-16 |
| K925450 | BIONOR TRANSPORTMEDIUM | Skoug Research Corp. | 1993-06-25 |
| K841220 | ANAEROBIC TRANSPORT MEDIUM | Anaerobe Systems | 1984-04-04 |
| K834357 | ANA TRANS TUBE & SWABS STERILE PACK | Anaerobe Systems | 1984-01-31 |
| K770840 | PRE-REDUCED ANAEROBIC MEDIA | Gibco Laboratories Life Technologies, Inc. | 1977-06-08 |