AMYLASE REAGENT #88129
FDA 510(k) clearance K831295 · decided 1983-06-30
Clearance details
- K-number
- K831295
- Device name
- AMYLASE REAGENT #88129
- Applicant
- Hi Chem, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-04-20
- Decision date
- 1983-06-30
- Days to decision
- 71 days
- Clearance type
- Traditional
- Product code
- KHM
- Device class
- 2
- Regulation number
- 862.1070
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AMYLASE (K812699) | Pointe Scientific, Inc., | 1981-10-06 |
| AMYLASE REAGENT KIT (K812447) | Bioscientific | 1981-09-09 |
| PERKIN ELMER MODEL 91 AMYLASE REAGENT (K801096) | Stat Engineering | 1980-06-09 |
| AMYLASE REAGENT SET (K790797) | Alta Diagnostics, Inc. | 1979-07-17 |
| REAGENT, AMYLASE LIPASE (K770400) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1977-04-26 |
Recalls involving this device
No recalls on record reference this clearance.