Pacific Biotech, Inc.
Mchenry, IL, US
Pacific Biotech, Inc. appears in FDA device records in Mchenry, IL. FDA records list 29 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 29
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 29 510(k) clearances for Pacific Biotech, Inc. between 1983 and 1993. The busiest year on record is 1986, with 7. The most recent is 1993, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 2 |
| 1984 | 4 |
| 1985 | 2 |
| 1986 | 7 |
| 1987 | 2 |
| 1988 | 4 |
| 1989 | 5 |
| 1990 | 2 |
| 1993 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K924461 | STREP A NEGATIVE CONTROL | GTZ | Substantially Equivalent | |
| K902510 | CARDS O.S. MONO | KTN | Substantially Equivalent | |
| K896482 | PERFECT(TM) ONE STEP EARLY PREGNANCY TEST KIT | LCX | Substantially Equivalent | |
| K896221 | CARDS O.S.(TM) STREP A | GTZ | Substantially Equivalent | |
| K895390 | CARDS O.S. (TM) HCG-URINE | JHI | Substantially Equivalent | |
| K891770 | HCG IRMA II | JHI | Substantially Equivalent | |
| K884616 | FIRSTDAY EARLY PREGNANCY TESTING KIT II | JHI | Substantially Equivalent | |
| K883742 | MODIFIED TSH IRMA KIT | JLW | Substantially Equivalent | |
| K884007 | CARDS(TM) MONO | KTN | Substantially Equivalent | |
| K882895 | MODIFIED BETA QUIK STAT EIA KIT | DHA | Substantially Equivalent | |
| K883639 | MODIFIED HCG IRMA KIT | JHI | Substantially Equivalent | |
| K881015 | FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT | JHI | Substantially Equivalent | |
| K873788 | CARDS(TM) HCG-SERUM/URINE CR-7503 AND CR-7504 | JHI | Substantially Equivalent | |
| K863341 | CARDS(TM) - EARLY PREGNANCY TEST | LCX | Substantially Equivalent | |
| K863647 | CARDS(TM) STREP A CATALOG NO. CR-7545 | GTZ | Substantially Equivalent | |
| K863199 | CARDS(TM) HCG-URINE | JHI | Substantially Equivalent | |
| K862007 | HCG IRMA, CAT. NO. CR-1501 | JHI | Substantially Equivalent | |
| K862249 | TSH IRMA KIT | JLW | Substantially Equivalent | |
| K861575 | DIRECTATEX STREP A | GTY | Substantially Equivalent | |
| K860945 | DIRECTACLONE CG SLIDE PREGNANCY TEST | JHJ | Substantially Equivalent | |
| K860965 | BETA QUIK STICK | JHI | Substantially Equivalent | |
| K852327 | BETA QUIK STAT | JHI | Substantially Equivalent | |
| K850383 | PRL QUIK RIA KIT | CFT | Substantially Equivalent | |
| K843795 | BETA QUIK V | JHI | Substantially Equivalent | |
| K843545 | TSH QUIK RIA KIT | JLW | Substantially Equivalent | |
| K840230 | FSH QUIK RIA KIT | CGJ | Substantially Equivalent | |
| K840174 | LH QUIK RIA KIT | CEP | Substantially Equivalent | |
| K831302 | PBI BHCG RIA KIT | JHI | Substantially Equivalent | |
| K831223 | BETA-QUIK-15 RIA KIT | JHI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JHJAgglutination Method, Human Chorionic Gonadotropin
- GTYAntigens, All Groups, Streptococcus Spp.
- GTZAntisera, All Groups, Streptococcus Spp.
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- DHASystem, Test, Human Chorionic Gonadotropin
- KTNSystem, Test, Infectious Mononucleosis
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain