HI VOLUME PUMPING CHAMBER
FDA 510(k) clearance K802561 · decided 1980-10-31
Clearance details
- K-number
- K802561
- Device name
- HI VOLUME PUMPING CHAMBER
- Applicant
- Acacia, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-10-16
- Decision date
- 1980-10-31
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- JTB
- Device class
- 1
- Regulation number
- 866.2440
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- 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 |
|---|---|---|
| I NETILMICIN RIA KIT (K790514) | Diagnostic Products Corp. | 1979-05-03 |
Recalls involving this device
No recalls on record reference this clearance.