KLENZYME
FDA 510(k) clearance K944950 · decided 1994-12-20
Clearance details
- K-number
- K944950
- Device name
- KLENZYME
- Applicant
- Calgon Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-10-07
- Decision date
- 1994-12-20
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- FLG
- Device class
- 1
- Regulation number
- 880.6150
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- St. Louis, MO, 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 |
|---|---|---|
| ALSA-KLENZ (K944494) | Calgon Vestal Div. | 1994-10-19 |
| BILL EVANS-KLENZ (K944033) | Calgon Vestal Div. | 1994-10-07 |
| MON-KLENZ (K941163) | Calgon Vestal Div. | 1994-05-18 |
| NPH-KLENZ (K940263) | Calgon Corp. | 1994-05-18 |
| INSTRU KLENZ (K935063) | Calgon Corp. | 1994-05-09 |
| PDS ULTRACLEAN (K934666) | Medical Polymers, Inc. | 1994-04-15 |
| SURGICLEAN ENZYMATIC INSTRUMENT CLEANER (K931270) | Surgicot, Inc. | 1994-04-13 |
| INSTRUMENT DETERGENT CONCENTRATE (K933149) | Nobelpharma USA, Inc. | 1994-02-16 |
| BIOSONIC ULTRASONIC CLEANING SYSTEM (K884660) | Whaledent Intl. Div. Ipco | 1989-03-16 |
| RAPIDEX BIOLOGICAL SURFACTANT (K862282) | Rapidex of London | 1987-05-11 |
| UCS-2, ULTRASONIC CLEANING SOLUTION (K861147) | Keymed, Inc. | 1986-06-23 |
| WEC-WASH, CATALOG NO. 850-115 (K861592) | Palmetto Chemical & Supply Co., Inc. | 1986-06-17 |
Recalls involving this device
No recalls on record reference this clearance.