Hillcrest Biologicals
Medical device manufacturer in Cypress, CA.
33510(k) clearances
0PMA approvals
0recalls
Device types
- LSR Reagent, Borrelia Serological Reagent 4
- JSM Culture Media, Non-Propagating Transport 3
- GNK Antisera, Cf, Echovirus 1-34 3
- GPJ Antiserum, Fluorescent, Q Fever 2
- GQC Antisera, Cf, Equine Encephalitis Virus… 2
- GNL Antigens, Cf (Including Cf Control)… 2
- GNG Antigens, Cf (Including Cf Control)… 1
- KIT Media And Components, Synthetic Cell And… 1
- GQN Antigen, Cf (Including Cf Control)… 1
- KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica… 1
- LJO Antigen, Iha, Cytomegalovirus 1
- GPW Antigen, Cf, Psittacosis (Chlamydia Group) 1
- GQI Antiserum, Cf, Cytomegalovirus 1
- GOG Antisera, Cf, Poliovirus 1-3 1
- GNO Antisera, Cf, Coxsackievirus A 1-24, B 1-6 1
- GPN Antiserum, Typhus Fever 1
- GRY Antigens, All, Leptospira Spp. 1
- LLM Test, Antigen, Nuclear, Epstein-Barr Virus 1
- GNP Antiserum, Cf, Epstein-Barr Virus 1
- GSB Antigens, Cf, All, Mycoplasma Spp. 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K913618 | Arbovirus Igm Ifa TestGQC · Traditional | 12/03/1992SE |
| K913617 | Arbovirus Igg Ifa TestGQC · Traditional | 12/03/1992SE |
| K922374 | Q Fever Igm Ifa TestGPJ · Traditional | 10/21/1992SE |
| K913906 | Q Fever Igg Ifa TestGPJ · Traditional | 10/21/1992SE |
| K900206 | Lyme Disease Igm ElisaLSR · Traditional | 06/28/1991SE |
| K896594 | Ebv Vca Antibody (Igm)LJN · Traditional | 01/16/1990SE |
| K884829 | Ebv Early Antigen (R+D)JRY · Traditional | 04/12/1989SE |
| K883767 | Lyme Disease Ifa (Igm)LSR · Traditional | 03/15/1989SE |
| K884591 | Ebv-Vca Antibody (Igg)GNP · Traditional | 01/24/1989SE |
| K883487 | Lyme Disease Ifa (Igg)LSR · Traditional | 12/13/1988SE |
| K875170 | Ebna AntibodyLLM · Traditional | 05/23/1988SE |
| K880476 | Lyme Disease ElisaLSR · Traditional | 04/26/1988SE |
| K880417 | Leptospirosis IhaGRY · Traditional | 04/12/1988SE |
| K864110 | Rickettsial Igg and Igm Ifa KitGPN · Traditional | 03/12/1987SE |
| K854715 | Transport Culture MediaJSM · Traditional | 12/23/1985SE |
| K853279 | Coxsackie A2 CF Antigen, A4, A10 & A16GNO · Traditional | 11/07/1985SE |
| K853278 | Polio Type I CF Antigen, & Type II, IIIGOG · Traditional | 11/07/1985SE |
| K853277 | CMV CF AntigenGQI · Traditional | 11/07/1985SE |
| K853165 | Echo Type 30 CF AntigenGNK · Traditional | 11/07/1985SE |
| K853157 | Echo Type 11 CF AntigenGNK · Traditional | 11/07/1985SE |
| K853156 | Echo Type 16 CF AntigenGNK · Traditional | 11/07/1985SE |
| K852494 | Cmv-IhaLJO · Traditional | 09/16/1985SE |
| K853448 | Hillcrest Amebiasis Iha TestKHW · Traditional | 08/28/1985SE |
| K850609 | Herpes Simplex Group CF AntigenGQN · Traditional | 05/09/1985SE |
| K850537 | Cell Culture Refeed MediumKIT · Traditional | 03/20/1985SE |
| K850003 | Coxsackie B Series CF AntigensGNG · Traditional | 03/05/1985SE |
| K844967 | Echo Type 9 CF AntigenGNL · Traditional | 03/05/1985SE |
| K844868 | Chlamydia Group CF AntigenGPW · Traditional | 03/05/1985SE |
| K844695 | Echo Type 4 CF AntigenGNL · Traditional | 03/05/1985SE |
| K850124 | Chlamydial Transport MediaJSM · Traditional | 03/04/1985SE |
| K844747 | Viral Transport MediaJSM · Traditional | 01/04/1985SE |
| K834338 | Mycoplasma Pneumoniae CF AntigenGSB · Traditional | 02/27/1984SE |
| K822095 | Herpes-Iha KitKLC · Traditional | 04/05/1983SE |