510(k) K782156
- Device
- Unitest Creatine Kinase
- Applicant
- BOEHRINGER MANNHEIM CORP.
- 510(k) number
- K782156
- Product code
- JLB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-03-02
- Date received
- 1978-12-22
- Regulation
- 862.1210
- Classification name
- Atp And Creatine Kinase (Enzymatic), Creatine
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 2939693
- 2032839
- 2032682
- 3021841051
- 3005984081
- 3006198300
- 3004493545
- 3003741796
- 2432235
Source Documents#
510(k) summary PDF not indicated by FDA