REAGENT SET, RENORPACE
FDA 510(k) clearance K770765 · decided 1977-06-24
Clearance details
- K-number
- K770765
- Device name
- REAGENT SET, RENORPACE
- Applicant
- G.D. Searle and Co.
- Decision
- Substantially Equivalent
- Date received
- 1977-04-27
- Decision date
- 1977-06-24
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- DPA
- Device class
- 1
- Regulation number
- 862.2270
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch G.D. Searle and 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 |
|---|---|---|
| DE-TOX TUBES A AND DE-TOX TUBES B (K904326) | Dyna-Tek Industries | 1991-01-17 |
| CHROMATOGRAPHY KIT (K884176) | Gelman Sciences, Inc. | 1989-04-04 |
| TECHNICON FAST-LC SYS. FOR THEOPHYLLINE (K791431) | Technicon Instruments Corp. | 1979-10-11 |
| MINIATURE ASCENDING PAPER CHROMATO- (K760908) | Ackerman Nuclear, Inc. | 1976-11-19 |
Recalls involving this device
No recalls on record reference this clearance.