Dupont 'Aca' Conjugated Bilirubin(Cbil)
FDA 510(k) K801300 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK801300
Submission
- Device name
- Dupont 'Aca' Conjugated Bilirubin(Cbil)
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Mchenry, IL, US - Received
- June 2, 1980
- Decision date
- July 8, 1980
- 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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| K902294 | Accuscan Microbead StandardsJIW · Traditional | Sigma Chemical Co. | 07/03/1990SE |
| K892213 | Acs Colloid Osmotic Pressure CalibratorJIW · Traditional | Analytical Control Systems, Inc. | 06/21/1989SE |
| K883389 | Raichem(Tm) Bilirubin Conjugate StandardJIW · Traditional | Reagents Applications, Inc. | 12/14/1988SE |
| K882220 | Calibration KitJIW · Traditional | King Diagnostics, Inc. | 08/02/1988SE |
| K880654 | Amresco Liquizyme Glucose/Bun Standard 0124, 0200JIW · Traditional | American Research Products Co. | 06/07/1988SE |
| K880610 | Unimeter Calibration KitJIW · Traditional | Boehringer Mannheim Corp. | 03/24/1988SE |
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Questions and answers
When was Dupont 'Aca' Conjugated Bilirubin(Cbil) cleared by the FDA?
Dupont 'Aca' Conjugated Bilirubin(Cbil) (K801300) received a 510(k) decision of Substantially Equivalent on July 8, 1980, 36 days after the submission was received.
What is the product code of K801300?
The FDA product code is JIW – Calibrator, Surrogate, a Class II (moderate risk) device regulated under 21 CFR 862.1150.