Company ยท CA
Pro-Lab, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1995. 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 |
|---|---|---|
| JSK | Supplement, Culture Media | 7 |
| JTO | Discs, Strips And Reagents, Microorganism Differentiation | 3 |
| FRG | Wrap, Sterilization | 2 |
| JSE | Culture Media, Multiple Biochemical Test | 2 |
| FSM | Tray, Surgical, Instrument | 1 |
| GNA | Antisera, All Types, Escherichia Coli | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 |
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | 1 |
| JSX | Kit, Identification, Neisseria Gonorrhoeae | 1 |
| JTR | Kit, Quality Control For Culture Media | 1 |
| LHL | Reagents, Antibody, Legionella, Direct & Indirect Fluorescent | 1 |
| LRP | Tray, Surgical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 27, 1995 | K934383 | PROLEX (STREPTOCCAL GROUPING LATEX KIT) Pro-Lab, Inc., CA | GTZ |
| Sep 1, 1993 | K914419 | AMNIOTEST(TM) Pro-Lab, Inc., CA | HIO |
| Jul 28, 1992 | K921421 | LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY Pro-Lab, Inc., CA | LHL |
| Jan 24, 1991 | K903714 | E. COLI 0157 LATEX TEST Pro-Lab, Inc. | GNA |
| Sep 28, 1989 | K894221 | ROSCO PYRR Pro-Lab, Inc. | JTO |
| Oct 12, 1988 | K883996 | X-ACT LDC/IND Pro-Lab, Inc. | JSE |
| Oct 12, 1988 | K883995 | X-ACT UREA/TDA Pro-Lab, Inc. | JSE |
| Apr 14, 1987 | K871121 | PROTECT T.M. Pro-Lab, Inc., CA | JTR |
| Mar 20, 1987 | K870117 | NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST Pro-Lab, Inc., CA | JSX |
| Jul 10, 1986 | K861142 | MASTER KIT B Pro-Lab, Inc. | LRP |
| Jun 3, 1986 | K861889 | D'ALA RAPID TEST Pro-Lab, Inc., CA | JTO |
| Jun 3, 1986 | K861888 | HIPPURATE HYDROLYSIS TEST Pro-Lab, Inc., CA | JTO |
| Apr 9, 1985 | K850246 | MASTER KIT A Pro-Lab, Inc. | |
| Mar 22, 1985 | K850302 | SUPLEX & SUPLEX DILUENT Pro-Lab, Inc., CA | JSK |
| Mar 20, 1985 | K850308 | C.L.A.T. Pro-Lab, Inc., CA | JSK |
| Mar 20, 1985 | K850307 | CAMPYLOBACTER SUPPLEMENT-BLASER/WANG Pro-Lab, Inc., CA | JSK |
| Mar 20, 1985 | K850306 | CAMPYLOBACTER SUPPLEMENT -SKIRROW Pro-Lab, Inc., CA | JSK |
| Mar 20, 1985 | K850301 | YEAST DIALYSATE Pro-Lab, Inc., CA | JSK |
| Mar 20, 1985 | K850300 | MUCOLYSE Pro-Lab, Inc., CA | JSK |
| Mar 20, 1985 | K850299 | C.N.V.T. Pro-Lab, Inc., CA | JSK |
| Mar 15, 1985 | K850072 | CUSTOM OPEN HEART TRAY Pro-Lab, Inc. | |
| Dec 5, 1984 | K843813 | INTRAVENOUS START KIT Pro-Lab, Inc. | |
| Dec 4, 1984 | K843627 | VENESECTION TRAY, ADULT 6050 Pro-Lab, Inc. | FSM |
| Dec 4, 1984 | K842404 | DRESSING CHANGE TRAY STERILE 5002 Pro-Lab, Inc. | |
| Nov 5, 1984 | K843525 | SUTURE TRAY Pro-Lab, Inc. | |
| Oct 31, 1984 | K843982 | O.B. BASIN SET Pro-Lab, Inc. | FRG |
| Aug 15, 1984 | K842405 | DR. GOULD HAND PACK SUSTOM STERIL Pro-Lab, Inc. | FRG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||