Nephelometric Solid Turbidity Standard
FDA 510(k) K812220 · Hyland Therapeutic Div., Travenol Laboratories
510(k) numberK812220
Submission
- Device name
- Nephelometric Solid Turbidity Standard
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
Mchenry, IL, US - Received
- August 6, 1981
- Decision date
- August 18, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JIW – Calibrator, Surrogate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1150
- Specialty
- Clinical Chemistry
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| K880610 | Unimeter Calibration KitJIW · Traditional | Boehringer Mannheim Corp. | 03/24/1988SE |
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Questions and answers
When was Nephelometric Solid Turbidity Standard cleared by the FDA?
Nephelometric Solid Turbidity Standard (K812220) received a 510(k) decision of Substantially Equivalent on August 18, 1981, 12 days after the submission was received.
What is the product code of K812220?
The FDA product code is JIW – Calibrator, Surrogate, a Class II (moderate risk) device regulated under 21 CFR 862.1150.