Chemelia Enzyme Immunoassay for (TSH)
FDA 510(k) K873625 · Boots-Celltech Diagnostics, Inc.
510(k) numberK873625
Submission
- Device name
- Chemelia Enzyme Immunoassay for (TSH)
- Applicant
- Boots-Celltech Diagnostics, Inc.
Berkshire, England, GB - Received
- September 8, 1987
- Decision date
- October 20, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JLM – Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7360
- Specialty
- Hematology
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| 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 Chemelia Enzyme Immunoassay for (TSH) cleared by the FDA?
Chemelia Enzyme Immunoassay for (TSH) (K873625) received a 510(k) decision of Substantially Equivalent on October 20, 1987, 42 days after the submission was received.
What is the product code of K873625?
The FDA product code is JLM – Isoenzymes, Electrophoretic, Glucose-6-Phosphate Dehydrogenase, a Class II (moderate risk) device regulated under 21 CFR 864.7360.