Albp
FDA 510(k) K981814 · Abbott Laboratories
510(k) numberK981814
Submission
- Device name
- Albp
- Applicant
- Abbott Laboratories
Irving, TX, US - Received
- May 22, 1998
- Decision date
- July 22, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CJW – Bromcresol Purple Dye-Binding, Albumin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1035
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CJW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K203530 | Albumin BCP2CJW · Traditional | Abbott Ireland Diagnostics Division | 03/18/2022SE |
| K193001 | Albumin BCPCJW · Traditional | SENTINEL CH. SpA | 12/19/2019SE |
| K132664 | Advia Chemistry Albumin BCP Reagent (Albp), Advia Chemistry Albumin BCP CalibratorCJW · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/16/2013SE |
| K021636 | Albumin ReagentCJW · Traditional | Intersect Systems, Inc. | 07/17/2002SE |
| K000483 | Randox AlbuminCJW · Traditional | Randox Laboratories, Ltd. | 03/31/2000SE |
| K990978 | Albumin BCG, Model Al 103-01CJW · Traditional | A.P. Total Care, Inc. | 05/25/1999SE |
| K981457 | AlbpCJW · Traditional | Abbott Mfg., Inc. | 05/27/1998SE |
| K913025 | Abbott Quickstart Albumin BCP (ALBP)#5A16CJW · Traditional | Em Diagnostic Systems, Inc. | 10/09/1991SE |
| K905776 | Albumin Reagent SetCJW · Traditional | Biochemical Trade, Inc. | 02/26/1991SE |
| K863226 | Albumin (BCP)CJW · Traditional | Sigma Diagnostics, Inc. | 09/17/1986SE |
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Questions and answers
When was Albp cleared by the FDA?
Albp (K981814) received a 510(k) decision of Substantially Equivalent on July 22, 1998, 61 days after the submission was received.
What is the product code of K981814?
The FDA product code is CJW – Bromcresol Purple Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.