REAGENT, AMYLASE LIPASE
FDA 510(k) clearance K770400 · decided 1977-04-26
Clearance details
- K-number
- K770400
- Device name
- REAGENT, AMYLASE LIPASE
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decision
- Substantially Equivalent
- Date received
- 1977-03-02
- Decision date
- 1977-04-26
- Days to decision
- 55 days
- Clearance type
- Traditional
- Product code
- KHM
- Device class
- 2
- Regulation number
- 862.1070
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Washington, DC, 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 REAGENT #88129 (K831295) | Hi Chem, Inc. | 1983-06-30 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| OXYCELL (N5798/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1995-07-24 |
| OXYCEL OXIDIZED (N5798/S005) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| OXYCELL (N5798/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1991-02-08 |
| MINI BALLOON (P780011/S012) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1989-10-30 |
| MINI BALLOON (P780011/S011) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-10-18 |
| MINI BALLOON (P780011/S010) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1988-01-29 |
| MINI BALLOON (P780011/S007) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1985-01-23 |
| BBL SCEPTOR SYSTEM MICRODILUTION ANTIMICROBIC SUSC (P800030/S006) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1984-11-05 |