510(k) K770400
- Device
- REAGENT, AMYLASE LIPASE
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- 510(k) number
- K770400
- Product code
- KHM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-04-26
- Date received
- 1977-03-02
- Regulation
- 862.1070
- Classification name
- Nephelometric, Amylase
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 1875 Eye St. NW Suite 625 Washington DC US 20006 20006
FDA Registration Numbers#
- 2432235
- 3004493545
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KHM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K831295 | AMYLASE REAGENT #88129 | Hi Chem, Inc. | 1983-06-30 |
| K812699 | AMYLASE | Pointe Scientific, Inc., | 1981-10-06 |
| K812447 | AMYLASE REAGENT KIT | Bioscientific | 1981-09-09 |
| K801096 | PERKIN ELMER MODEL 91 AMYLASE REAGENT | Stat Engineering | 1980-06-09 |
| K790797 | AMYLASE REAGENT SET | Alta Diagnostics, Inc. | 1979-07-17 |