GDH-GLUCOSE (RATE) REAGENT KIT
FDA 510(k) clearance K770062 · decided 1977-01-26
Clearance details
- K-number
- K770062
- Device name
- GDH-GLUCOSE (RATE) REAGENT KIT
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-01-11
- Decision date
- 1977-01-26
- Days to decision
- 15 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Beckman Instruments
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.