ALKALINE PHOSPHATASE ISOYZME REAGENT SET
FDA 510(k) clearance K770155 · decided 1977-01-31
Clearance details
- K-number
- K770155
- Device name
- ALKALINE PHOSPHATASE ISOYZME REAGENT SET
- Applicant
- Gelman Instrument Co.
- Decision
- Substantially Equivalent
- Date received
- 1977-01-24
- Decision date
- 1977-01-31
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- CJO
- Device class
- 2
- Regulation number
- 862.1050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Gelman Instrument Co.
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.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DIMENSION VISTA ALKALINE PHOSPHATASE (ALPI) FLEX REAGENT CARTRIDGE DIMENSION VISTA ALKALINE PHOSPHATASE CALIBRATOR (ALPI (K122323) | Siemens Healthcare Diagnostics | 2012-08-28 |
| DIMENSION ALKALINE PHOSPHATASE FLEX REAGENT CARTRIDGE, DIMENSION ALKALINE PHOSPHATASE CALIBRATOR (K121907) | Siemens Healthcare Diagnostics | 2012-07-23 |
| BAYER ADVIA IMS SYSTEM (IN VITRO DIAGNOSTIC SYSTEM) (K982328) | Bayer Corp. | 1999-01-29 |
Recalls involving this device
No recalls on record reference this clearance.