Albumin BCG, Model Al 103-01
FDA 510(k) K990978 · A.P. Total Care, Inc.
510(k) numberK990978
Submission
- Device name
- Albumin BCG, Model Al 103-01
- Applicant
- A.P. Total Care, Inc.
Bridgeport, CT, US - Received
- March 23, 1999
- Decision date
- May 25, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K981814 | AlbpCJW · Traditional | Abbott Laboratories | 07/22/1998SE |
| 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 |
More from Sigma Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K991246 | Fructosamine, Model FR 106-01LCP · Traditional | 12/16/1999SE |
| K991762 | Alkaline Phophatase (Alp), Product No's 118-01, 118-02CJE · Traditional | 09/02/1999SE |
| K991761 | Magnesium Product No's, 112-01, 112-02JGJ · Traditional | 09/02/1999SE |
| K991664 | LDL Cholesterol, Product No's, 124-01, CH102-01LBS · Traditional | 08/19/1999SE |
| K991665 | HDL Cholesterol, Product No's 124-01, CH102-01LBS · Traditional | 08/10/1999SE |
| K991867 | Inorganic Phosphorus (Ip), Product No's, 112-01, 112-02CEO · Traditional | 08/02/1999SE |
| K991866 | Bilirubin, Total and Direct, Product No, 122-01, 122-02, 122-03, 122-04CIG · Traditional | 08/02/1999SE |
| K991870 | Electrolytes (Na+, K+, Cl-), Product No's 114-01, 114-02, 114-03CGZ · Traditional | 07/30/1999SE |
| K991666 | Tibc, Product No's 123-0, 123-02, FE109-01, FE109-02JMO · Traditional | 06/30/1999SE |
| K991663 | Ast/SgotCIT · Traditional | 06/30/1999SE |
Questions and answers
When was Albumin BCG, Model Al 103-01 cleared by the FDA?
Albumin BCG, Model Al 103-01 (K990978) received a 510(k) decision of Substantially Equivalent on May 25, 1999, 63 days after the submission was received.
What is the product code of K990978?
The FDA product code is CJW – Bromcresol Purple Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.