Company ยท US
Biotope, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 1991. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| DPO | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep. | 1 |
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 26, 1991 | K905145 | ECLIPSE ICA CHOLESTEROL Biotope, Inc. | CHH |
| Feb 22, 1991 | K910302 | ECLIPSE ICA ANALYZER Biotope, Inc. | JJQ |
| Feb 22, 1991 | K910256 | ECLIPSE ICA TSH Biotope, Inc. | JLW |
| Jan 17, 1991 | K905719 | ECLIPSE ICA DIGOXIN Biotope, Inc. | DPO |
| Jan 17, 1991 | K905601 | ECLIPSE ICA TRIGLYCERIDES Biotope, Inc. | CDT |
| Jan 16, 1991 | K905602 | ECLIPSE ICA BUN Biotope, Inc. | CDQ |
| Jan 4, 1991 | K905144 | ECLIPSE ICA GLUCOSE Biotope, Inc. | CFR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||