Delfia HLH Spec Kit
FDA 510(k) K883814 · Pharmacia, Inc.
510(k) numberK883814
Submission
- Device name
- Delfia HLH Spec Kit
- Applicant
- Pharmacia, Inc.
Piscataway, NJ, US - Received
- September 8, 1988
- Decision date
- March 8, 1989
- 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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Questions and answers
When was Delfia HLH Spec Kit cleared by the FDA?
Delfia HLH Spec Kit (K883814) received a 510(k) decision of Substantially Equivalent on March 8, 1989, 181 days after the submission was received.
What is the product code of K883814?
The FDA product code is CEP – Radioimmunoassay, Luteinizing Hormone, a Class I (low risk) device regulated under 21 CFR 862.1485.