Company ยท US
American Laboratory Products Co., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2002. Name variants (Inc, Corp, punctuation) are merged.
27510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JZO | System, Test, Thyroid Autoantibody | 9 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 6 |
| MID | System, Test, Anticardiolipin Immunological | 3 |
| KQN | Radioassay, Angiotensin Converting Enzyme | 2 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 |
| CDD | Radioassay, Vitamin B12 | 1 |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 1 |
| DAK | Complement C1q, Antigen, Antiserum, Control | 1 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 29, 2002 | K012576 | CIC-C1Q EIA American Laboratory Products Co., Ltd. | DAK |
| May 30, 2001 | K011415 | ALPCO MILENIA ANTI-TG EIA American Laboratory Products Co., Ltd. | JZO |
| May 24, 2001 | K011201 | ALPCO MILENIA ANTI-TPO ELISA American Laboratory Products Co., Ltd. | JZO |
| Feb 17, 1998 | K974702 | ORGENTEC ANTI-PR3 (C-ANCA) ELISA American Laboratory Products Co., Ltd. | MOB |
| Feb 17, 1998 | K974701 | ORGENTEC ANTI-MPO (P-ANCA) ELISA American Laboratory Products Co., Ltd. | MOB |
| Jul 14, 1997 | K972190 | THYROGLOBULIN ASSAY SYSTEM American Laboratory Products Co., Ltd. | JZO |
| Apr 8, 1997 | K970932 | ORGENTEC MICRO-ALBUMIN EIA ASSAY American Laboratory Products Co., Ltd. | JIR |
| Nov 18, 1996 | K962062 | ORGENTEC ANTI-SM ELISA American Laboratory Products Co., Ltd. | LJM |
| Nov 18, 1996 | K962057 | ORGENTEC ANTI-RNP/SM ELISA American Laboratory Products Co., Ltd. | LJM |
| Nov 15, 1996 | K962055 | ORGENTEC ANTI-SCL 70 ELISA American Laboratory Products Co., Ltd. | LJM |
| Nov 15, 1996 | K962054 | ORGENTEC ANTI-SS-A(RO) ELISA American Laboratory Products Co., Ltd. | LJM |
| Nov 15, 1996 | K962053 | ORGENTEC ANTI-JO-1 ELISA American Laboratory Products Co., Ltd. | LJM |
| Nov 15, 1996 | K962052 | ORGENTEC ABTI-SS-BB(LA) ELISA American Laboratory Products Co., Ltd. | LJM |
| Nov 1, 1996 | K963911 | ALPCO/MERCODIA INSULIN ELISA American Laboratory Products Co., Ltd. | CFP |
| Oct 10, 1996 | K962926 | ORGENTEC ANTI-CARDIOLIPIN SCREEN ELISA ASSAY American Laboratory Products Co., Ltd. | MID |
| Sep 9, 1996 | K962469 | ORGENTEC ANTI-CARDIOLIPIN IGA ELISA ASSAY American Laboratory Products Co., Ltd. | MID |
| May 23, 1996 | K955561 | BUHLMANN VITAMIN B6 REA American Laboratory Products Co., Ltd. | CDD |
| May 23, 1996 | K955449 | ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY American Laboratory Products Co., Ltd. | MID |
| Jul 18, 1995 | K952055 | ORGEN TEC ANTI-DSDNA PIN IMMUNO ASSAY American Laboratory Products Co., Ltd. | LRM |
| Jun 20, 1995 | K952130 | ORGENTEC ANTI-TG ELISA American Laboratory Products Co., Ltd. | JZO |
| Jun 20, 1995 | K952129 | ORGENTEC ANTI-TPO ELISA American Laboratory Products Co., Ltd. | JZO |
| Apr 24, 1995 | K950217 | ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY) American Laboratory Products Co., Ltd. | JZO |
| Apr 21, 1995 | K950090 | ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY) American Laboratory Products Co., Ltd. | JZO |
| Apr 21, 1995 | K950089 | ORGENTEC ANTI-TG PIA (PIN IMMUNO ASSAY) American Laboratory Products Co., Ltd. | JZO |
| Apr 21, 1995 | K950088 | ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY) American Laboratory Products Co., Ltd. | JZO |
| Nov 15, 1994 | K942497 | ANGIOTENSIN CONVERTING ENZYME REA American Laboratory Products Co., Ltd. | KQN |
| Aug 26, 1991 | K913091 | BUEHLMANN LAB AS, ACE ANGIO CONV ENZYME KIN ASSAY American Laboratory Products Co., Ltd. | KQN |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||