Sucrosep Specific Immunoradiometric Assay
FDA 510(k) K880758 · Boots-Celltech Diagnostics, Inc.
510(k) numberK880758
Submission
- Device name
- Sucrosep Specific Immunoradiometric Assay
- Applicant
- Boots-Celltech Diagnostics, Inc.
Berkshire, England, GB - Received
- February 25, 1988
- Decision date
- April 18, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CEP – Radioimmunoassay, Luteinizing Hormone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1485
- Specialty
- Clinical Chemistry
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| K872958 | Imagen Influenza Virus a and B TestmiGNX · Traditional | 02/24/1988SE |
| K872843 | Oveia (TM) Dual AnalyteJLP · Traditional | 02/02/1988SE |
| K873625 | Chemelia Enzyme Immunoassay for (TSH)JLM · Traditional | 10/20/1987SE |
| K872056 | Modified (Directions for Use) for Ideia(Tm) TestLJC · Traditional | 06/15/1987SE |
| K870602 | Imagen Herpes Simplex Virus (HSV) Typing TestGQN · Traditional | 05/08/1987SE |
| K864998 | Ideia(Tm) Chlamydia Specimen Collection KitJSM · Traditional | 04/20/1987SE |
| K864539 | Modified Imagen(Tm) Chlamydia TestLJP · Traditional | 03/12/1987SE |
Questions and answers
When was Sucrosep Specific Immunoradiometric Assay cleared by the FDA?
Sucrosep Specific Immunoradiometric Assay (K880758) received a 510(k) decision of Substantially Equivalent on April 18, 1988, 53 days after the submission was received.
What is the product code of K880758?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.