510(k) K801096
- Device
- PERKIN ELMER MODEL 91 AMYLASE REAGENT
- Applicant
- STAT ENGINEERING
- 510(k) number
- K801096
- Product code
- KHM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-06-09
- Date received
- 1980-05-09
- Regulation
- 862.1070
- Classification name
- Nephelometric, Amylase
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
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 |
| K790797 | AMYLASE REAGENT SET | Alta Diagnostics, Inc. | 1979-07-17 |
| K770400 | REAGENT, AMYLASE LIPASE | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-04-26 |
Legacy Summary#
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FDA Review#
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