Amersham TSH Control Sera
FDA 510(k) K902760 · Amersham Corp.
510(k) numberK902760
Submission
- Device name
- Amersham TSH Control Sera
- Applicant
- Amersham Corp.
Arlington Heights, IL, US - Received
- June 25, 1990
- Decision date
- July 27, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K901854 | GADOLINIUM-153 Bone Densitometer (GDC.10411/10412)KGI · Traditional | 07/09/1990SE |
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| K901832 | GADOLINIUM-153 Bone Densitometer Sources GDC.10415KGI · Traditional | 07/09/1990SE |
| K896270 | Amerlite ESTRADIOL-60 Assay LAN.0081/2081CHP · Traditional | 12/12/1989SE |
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Questions and answers
When was Amersham TSH Control Sera cleared by the FDA?
Amersham TSH Control Sera (K902760) received a 510(k) decision of Substantially Equivalent on July 27, 1990, 32 days after the submission was received.
What is the product code of K902760?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.