FLEXIGRAM AUTO LOADER SYSTEM
FDA 510(k) clearance K811525 · decided 1981-06-18
Clearance details
- K-number
- K811525
- Device name
- FLEXIGRAM AUTO LOADER SYSTEM
- Applicant
- Electro-Nucleonics Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-05-29
- Decision date
- 1981-06-18
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- JJG
- Device class
- 1
- Regulation number
- 862.2140
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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| BIOMEK 1000C AUTOMATED LABORATORY WORK STATION (K871838) | Beckman Instruments, Inc. | 1987-05-26 |
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Recalls involving this device
No recalls on record reference this clearance.