Biotope, Inc.
Redmond, WA, US
Biotope, Inc. appears in FDA device records in Redmond, WA. FDA records list 7 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 7
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 7 510(k) clearances for Biotope, Inc. in 1991.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 7 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K905145 | ECLIPSE ICA CHOLESTEROL | CHH | Substantially Equivalent | |
| K910302 | ECLIPSE ICA ANALYZER | JJQ | Substantially Equivalent | |
| K910256 | ECLIPSE ICA TSH | JLW | Substantially Equivalent | |
| K905719 | ECLIPSE ICA DIGOXIN | DPO | Substantially Equivalent | |
| K905601 | ECLIPSE ICA TRIGLYCERIDES | CDT | Substantially Equivalent | |
| K905602 | ECLIPSE ICA BUN | CDQ | Substantially Equivalent | |
| K905144 | ECLIPSE ICA GLUCOSE | CFR | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- CFRHexokinase, Glucose
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- DPORadioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain